INTRODUCTION:

Pharma market is now a days one of the fastest growing sector of Bangladesh. Considering 1950 to present, significant changes taken place. The MNC domination, as detailed by the Tariff Commission has totally turned around. The NDP allowed volume sale products like vitamins, enzymes and cough syrups to the local companies and fixed a lot many conditions to the MNCs that crippled their opportunity of sale and invest further on manufacturing plant rather than an import-based house. A former volume drug importing country, Bangladesh is now converted to export-oriented country, adapting newer technologies and flourished opportunities of contract manufacturing for both home and abroad. An Annual growth of 10% every year for the last decade, the market size is turned 1.6 billion in 2015 from 28.416 million in 2004 (IMS 2015). 98% of local demand served by the market along with a little volume import of vaccines, hormonal and anti-cancer drugs. The growth was nearly 18% average between the years 2011-2015. Indeed, the true growth of local pharmaceutical industries began after the 1982’ ordinance came into effect, to limit the massive import of drugs and encourage local drug production. The market is focused on generic drugs, comprising 80% of the total market, enjoying the lowest labor cost to get a steady growth over the last 20 years.

Regulatory regime:

The DGDA (Directorate General of Dug administration) regulates the overall export, import, manufacturing, sales and distribution which is under the Ministry of Health and Family Welfare (MHFW). The PCB (Pharmacy Council of Bangladesh) was established through Ordinance 1976, considered as the controlling authority of pharmacy education and practice. BPS (Bangladesh Pharmaceutical Society), affiliated with Commonwealth Pharmaceutical Association and International Pharmaceutical Federation.

Government Incentive:

This sector is considered as a thrust sector in the export policy since 2006. Customs duty on 40 basic raw materials used in drug manufacturing was reduced to 5% from 10%-25% rate. Customs duty on 14 items used in anti-cancer drugs have been withdrawn. (Budget 2014-15).

Raw material custom duty is reduced by the government to facilitate the industry. The government recently sanctioned 200 acres of land for the API Park in Munshiganj. A 10% cash incentive is also under consideration by the authority to boost pharma sector.

Products of The Pharmaceutical Industry:

The Directorate General of Drug Administration under the Ministry of Health & Family Welfare, Govt. of Bangladesh, is the Drug Regulatory Authority of the country. This Directorate supervises and implements all prevailing Drug Regulations in the country and regulates all activities related to import and procurement of raw and packing materials, production and import of finished drugs, export, sale, pricing, etc. of all kinds of medicine including those of Ayurvedic, Unani, Homoeopathic and Herbal systems. Among complementary medicine arena, at present there are 295 Unani, 201 Ayurvedic, 15 Herbal, 79 Homeopathic and nearly 300 allopathic companies operating in Bangladesh⁽¹⁾.

Industry at a Glance:

A. Local Market Overview:

It’s predominantly a branded generic marketplace. They can either sell to the private sector pharmacies, to the government and its public health care establishments (HCEs), or to international organizations like UNICEF. The top 20 companies Pharma are having a combined market share of near 80% of the total pharmaceutical market of the country. Bangladesh Association of Pharmaceutical Industries (BAPI) was instituted in 1972, since then BAPI playing a pivotal role in shape up of the industry⁽²⁾.

B. Industry Structure:

The industry has distinct features, first, R&D activity is virtually nil, it is a branded generic market. Companies basically manufacture finished products by assembling known generic and patented (in some cases) product combination. Some companies are engaged in API production, the core of pharmaceutical products, but productions limited to synthesis stage (final stage) only.

C. Segmentation:

I. The primary layer is R&D Activities. This is often a very costly and high-risk business, and for many of global Pharmaceutical firms, represent the majority of costs. However, in Bangladesh, this activity is nil, and all the firms are producers of known and established drugs.

II. The second layer is manufacture of ingredients for finished formulations. These activities cover production of Active Pharmaceuticals Ingredients (API), solvents and excipients used as raw material for drug formulations. Historically, Bangladesh is an import dependent country for API and others. The local manufacturers arrange raw materials from China, India, Japan, Germany, France, Holland, Italy, Switzerland, Austria, Hungary, Ireland etc.

III. The final layer concerns producing final products, finished formulations. In this layer, there are both patented and generic products. However, in Bangladesh, only generic products are produced. Formulations represent the mainstream business in pharmaceuticals industry of Bangladesh. Presently, the market consists of approximately 8000 generic products and 258 firms with manufacturing capability, along with some imported patented products⁽³⁾.

D. Business nature:

1. High-End BiotechProducts (Anti-Cancer, Insulin, Vaccines etc.):

These are essentially products specific to market niches, i.e. Anti-cancer, Diabatic products, Vaccines etc. these products are usually high priced and represent a small portion of the market. Profit margin in such products is very high. Recently, domestic firms have been entering into this field, and competition is expected to drive prices and import dependency down.

2. Branded generics (Anti-Gastric, Anti-Biotic etc.):

This represents broadest segment of the market, comprising products with relatively stable margin and Brand orientation. This segment is dominated by local manufacturers, and due to high brand loyalty observed in our market, market share of manufacturers is usually moving rarely.

3. Low End generics:

This segment is small, often for products with low branding possibility, and price war is most evident here. The number of competitors is very high, and market share of each competitor depends on success of marketing strategy^(4).

4. Contract manufacturing (Domestic and export):

Locally, this segment is small as almost every firm manufactures its own products. The business usually comes from Health organizations like SMC (Social Marketing Company), UNICEF etc. to provide products such as saline, contraceptives etc.

Presently, a number of top firms engage in contract manufacturing. Competition is very low, as each firm engages based on foreign counterpart relations. Manufacturing technologies and accreditations play a vital role in developing contract manufacturing capability.

E. Export:

Export of pharmaceutical products of Bangladesh is still in a beginning stage. But the rate of establishment of pharmaceuticals industries in private sector is increasing and they have already entered the export market with their finished products. In 2000, Bangladesh imported USD 84,000,000 worth of medicinal and pharmaceutical products and had negligible exports and some recent statements by industry representatives suggest that exports will increase in the near future. Bangladesh is exporting their pharmaceuticals products to Vietnam, Singapore, Myanmar, Bhutan, Nepal, Sri Lanka, Pakistan, Yemen, Oman, Thailand, and some countries of Central Asia and Africa. It also has a large market in European countries.

F. Import:

The import is mostly from nearby countries, especially from India and China. Different organizations of this country are related to import the pharmaceuticals products and raw materials of pharmaceutical industries. Novo and Medintis are importing maximum amount of these types of products. Other organizations are engaging to import the pharmaceuticals products. They are- Sanofi, Aventis, GSK (now closing operation), Sandoz, Novartis, Roche, Unimed, Servier etc.

G. Foreign Competitions:

The beginning was dominated by MNCs.Still now, Pharmaceuticals industries are facing foreign competition. But our industry is not afraid of this foreign competition. There are manymultinational pharmaceutical organizations which have established their plants in Bangladesh and importing their raw materials from abroad. Among thesecompetitors, Roche, Novartis are leading. In export market, the Novartis is playing the dominant role. GSK, Organon, ICI, Pfizer closed their operation at different time periods.

H. Dumping:

Some Chinese and Indian companies are selling their products by luggage parties, imported unethically. Bangladeshi medicines but the medicine of developed countries and their origin country are sold in a competitive price, even in higher price. This creates the barrier to capture the market share by Bangladeshi pharmaceutical industries. Owners of the pharmaceutical companies think that the government should take actions to stop this practice⁽⁵⁾.

I. Problems of Marketing:

· A lack of sufficient compensation benefits and job nature cause the medical representative turnover.

· Cost of marketing is not feasible compared to sale volume or product price more often.

· Professionalism in sales profession is not achieved properly rather we can say declined in the past few years.

· Lack of proper vigilance by the government authorities on sales marketing activities, specially many of them using gimmicks for raising sales volume.

· Uncertainties in terms of political turmoil and violence.

· Competition raised due to globalization.

· Smuggled drugs from neighbor countries, substandard and counterfeit drugs.

J. Four important JOB SCOPES in Pharmaceutical industries:

1. Pharmaceutical Marketing: Medical Services Department (MSD), Product Management Department (PMD), Clinical Services, Training field forces, Sales Promotion/Medical Promotion and International Marketing (IM) departments.

2. Pharmaceutical industries (Finished medicines, Active Pharmaceutical Ingredients/APIs, and Excipients Manufacturing industries): In Production, Quality Control (QC), Quality Assurance (QA), Product Development (PD), cGMP Training, Warehouse, Drug Research and Invention, and Technical Services Department (TSD).

3. Drug Testing Laboratories (Dhaka and Chittagong)

4. Research & Development in Pharma industries, educational and research institutes (Research for new drug molecules, Novel Drug Delivery Systems, Improved Healthcare, Clinical aspects, etc.)⁽⁶⁾.

K. Key points of National Drug Policy of 1982:

· To provide administrative and legislative support to ensure quality of essential drugs

· Ensures the lowest competitive price to reduce healthcare cost.

· To develop proper drug monitoring and information system to prevent wasteful misuse and to ensure the proper utilization of the drugs.

· To ensure GMP and qualified pharmacist in manufacturing companies.

· To eliminate non-essential drug products from the market.

· To promote local drug and raw materials production.

L. Some major characteristics of BD drug marketing sector:

· Medical representatives are the key personnel in marketing.

· Distributional channel includes invoice system having own distribution channel.

· Surgeons and doctor groups are targeted for promotion

· Major promotional strategies include printed physical sample, promotional materialsand clinical materials.

· Cash incentives/costly gifts are given to the doctors. For example, honeymoon packages, pleasure trip, treats in luxury restaurants

· The cash/gifts and other kinds are not the sole of promotion, the most important thing is to counter watch of prescription share of that doctor⁽⁵⁾.

M. API Business:

In Bangladesh, companies have only recently entered API business. At present, there are 21 companies in Bangladesh manufacturing 41 APIs. Industry participants claim already becoming self-sufficient in some APIs, namely, Penicillin, Cephalexin, NSAID and Anti-Pyretic. The production of APIs is confined to the last stage of Synthesis. Presently, Local APIs take a 20% share in domestic production. The rest 80% is imported. These imported APIs represent majority of raw materials import by Bangladesh, approximately 70%. But the overall production is very low compared to total demand. While the industry is achieving self-sufficiency, it yet procures 90% of raw materials from 98 indenters around the world as only one company (Active Fine Chemicals) produces raw materials independently. There are 3000 valid sources of raw materials including countries like China, India, Korea & Italy. API consists a significant percent of total cost in medicine which can run up to 30-40%. At present, only a few companies – Square, Beximco, Ganasastha Pharmaceuticals, Globe and Active Fine – are manufacturing raw materials for drugs like paracetamol, amoxicillin, flucloxacillin, ampicillin and metformin, on a limited scale. Ganashastha Pharmaceuticals Limited (GPL) alone accounts for about 60% of the raw materials manufactured in Bangladesh. Bangladesh is trying to establish an industrial park for pharmaceutical production. One such park in Munshiganj near Dhaka is nearing completion and it might result in a big jump in the income from pharmaceutical exports. A National Control Laboratory Project is taken by the govt. for facilitating the pharmaceutical sector. The proposed API technology Park in Munshiganj, which was scheduled to be completed by July 2012, is delayed with the cost of the project now increasing by 55%. This delay has been a major hurdle for the pharmaceutical industry to gain better control over the inputs and improve operational efficiencies. India, the major generic drug player, has more than 3500 Drug Master File (DMF) approval for APIs whereas we have none⁽⁷⁾.

N. Access to essential drugs:

Although officially 80% of population has access to affordable essential drugs, there is plenty of evidence of a scarcity of essential drugs in government healthcare facilities. One study conducted in four district hospitals and one medical college hospital showed that only eight per cent of patients received the prescribed medicines from these facilities. In another report, two major hospitals in the capital city of Dhaka were operating without essential medicines for eight consecutive weeks. There are countless such incidents relating to the supply of essential medicines in Bangladesh. In most such cases, government officials and health professionals are responsible for the shortage as they often sell government-supplied drugs to local drug stores instead of dispensing them to poor patients. The government must be cognizant of this fact, but rarely takes any action.

O. Quality of available drugs:

Only 20 to 25 top pharmaceutical companies among the 300 produce drugs of standard quality. Reports show that numerous small companies’ market substandard drugs in the country. Fake or substandard medicines, including lifesaving ones, with an estimated worth of USD 150million per year, are flooding the domestic market. In its annual testing in 2004, the government laboratory detected 300 counterfeit or very poor-quality drugs out of 5,000 drug samples. A recent assay involving 15 brands of ciprofloxacin showed that nearly 50% of samples contained less than the specified amounts of the active ingredient. Another report noted that 69 per cent of paracetamol tablets and 80 percent of ampicillin capsules produced by small companies were of substandard quality. Good manufacturing practice (GMP) is a major criterion to maintain standard quality in drugs, and it was one of the principal objectives of the NDP to ensure standard manufacturing practices for drug manufacturers. But there are some 265 pharmaceutical companies in Bangladesh that do not follow or comply with GMP. It is widely alleged that adulteration flourishes in the country becauseof poor government vigilance and supervision over drug manufacturers and sellers. Unfortunately, a section of corrupt physicians and government officials is involved in these under hand dealings. The government states that it has limited manpower and facilities to cope with the country’s fast expanding pharmaceuticals sector. In fact, the regulatory authorizes have given scant attention to quality matters in Bangladesh.

P. Lack of control over drug prices:

In Bangladesh the maximum retail price (MRP) of every essential drug is fixed by the Directorate of Drug Administration (DDA); for all other drugs the DDA endorses the companies’ quoted prices. Drug prices are quite highin Bangladesh in comparison to neighboring countries. Thedrugs control authority is apparently reluctant to negotiate with the companies to fix prices. The regulatory authorities have virtually no control over drug prices in Bangladesh. Indiscriminate pricing can be observed in all therapeutic classes of drugs. For example, prices of various ciprofloxacin brands range from Taka (Tk) 5 to 14 (US$ 0.07 to 0.20) per unit. The price of dexamethasone eyedrops extends from Tk 24to 90 (US$ 0.34 to1.29) per 5ml, and diclofenac eye drops are available at a price range from Tk 40 to 200 (US$ 0.57 to 2.86) per unit. These are a few of the existing price discrepancies in the country. Easy excessive profits made pharma companies reckless and making misleading statements implicating of Dollar Taka conversion rate as a reason for increase price. As a counter misinformation, continuously propagating that pharma exports will soon overtake garment export. Present pharma export is not even 1 percent of total national export.

Q. Patterns of drug use:

To ensure rational and appropriate use of drugs in Bangladesh was another prime concern of the NDP. But there has been no drug use study in the country. Clinically in appropriate and inefficient use of medicines is a serious problem. More than half the medicines in Bangladesh are inappropriately prescribed, dispensed or sold. Despite legal prohibitions, numerous drugs with similar or no significant benefits are available in the market. As a specific example, there are seven members of the angiotensin-converting enzyme (ACE) inhibitors available in the country. The efficacies and chemical structures of these molecules are more or less similar, but their price vary significantly. The drug policy clearly prohibits the production of multi-ingredient preparations of vitamins and minerals with the exception of B-complex vitamins. But a mixture of 32 vitamins and minerals including selenium, vanadium, molybdenum, tin and many other unnecessary ingredients has been marketed in the country for a few years, violating the principles of the NDP. The need for these trace elements in Bangladesh is not established whereas nutritional deficiencies are mainly related to vitamins A and B-complex, iron, calcium, iodine and zinc. Irrational prescription and use of antibiotics are rampant throughout the country, with an estimated half of all antibiotics being sold without prescriptions. Self-medication is widespread, and all typesof medicines can be purchased without a prescription. There are about 30,000 illegal and 80,000 unlicensed drug stores operating in the country. It is alleged that both legal and illegal drug dealers are engaged in selling fake, smuggled and adulterated medicines in the country⁽⁸⁾.

R. Domestic drug distribution:

Bangladesh’s drug market place is composed of small independent pharmacies. This structure combined with an under-regulated industry, few firms manufacturing pharmaceuticals, and companies competing to sell branded generics based on brand names provide sample opportunity for the sale of low-quality drugs at higher prices. And this partly explains why the quality of drugs available for sale varies significantly in Bangladesh. Pharmaceutical firms can sell their products to private sector pharmacies, the government and its public health care facilities, or to international organizations operating in Bangladesh (e.g., UNICEF). Although there are approximately 200,000 private pharmacies in Bangladesh, the government lists officially only 76,000 pharmacies. The rest are illegal, without a license or a licensed pharmacist on staff. Pharmacists have varying education levels and many lacks adequate training. For example, a visit to four pharmacies in Dhaka and ten pharmacies in the bordering Gazipur, Narayanganj, Keranigonj and Manikgonj Districts revealed that each had one professional pharmacist, who had four years of coursework; while the two medium-sized pharmacies visited had one person with a year’s training and several untrained coworkers, all of whom were working as pharmacists. Rural pharmacies may have pharmacists with high school education and approximately two weeks training. The Bangladesh Pharmacist Society is currently implementing the first phase of a three-phased program to improve skills of pharmacists. The program should be completed in seven to eight years. Most pharmacies are individual shops, though some chains are starting to develop, especially in urban areas. Large pharmacies visited reported buying medicines according to sales trends, e.g., what sells the most. The medium and small pharmacies visited reported linkages with a medical doctor. Their sales were therefore usually skewed towards that medical professional’s preferences. Several brands of each drug, with variable quality levels, are on the market. In urban areas, the visited pharmacies tended to sell higher quality brands, whereas in more rural areas, pharmacies visited tended to sell lower quality, lower cost brands. This may be due to a district’s political sway influencing brand selection. The pharmacies visited tended to have brands associated with people who held power in that district. Those more distant from the city center also had increasingly more ayurvedic and herbal medicines. The top 20 pharmaceutical manufacturing firms have established extensive sales and distribution networks. Each pharmacy visited has 10-50 pharmaceutical firms supplying their medicines daily. For example, Beximco Pharmaceuticals has 1,200 representatives visiting pharmacies daily to take drug orders. Each pharmacy receives approximately 12- 15 Beximco shipments per month. Acme Pharmaceuticals has 1,100 representatives and Square Pharmaceuticals has 950 representatives visiting pharmacies. None of the pharmacies visited restock any medicine that does not sell well. The small pharmacies report only keeping a medicine for a maximum of six months. A significant number of drug consumers obtain drugs without a prescription. When consumers lack a prescription, they will usually either ask a pharmacist for a specific drug or describe their ailment to a pharmacist who diagnoses the problem and recommends a drug on the spot. Popular products include a variety of antibiotics, painkillers, and gastric remedies. Consumers purchase one to ten tablets or capsules at a time. The quantity of drugs purchased often depends more on the consumer’s finances of than on the required dose of ⁽²⁾.

S. Most pharma companies tempt doctors with 'gifts': With a view to popularizing their brands, most of the pharmaceutical companies in the country allegedly practice unethical drug promotion alluring doctors with free samples and gifts to prescribe their medicines.To stop such unethical promotion of drugs, there was no effective implementation of the Drugs (Control) Ordinance, 1982 that regulates manufacture, import, distribution and sale of drugs in Bangladesh.The Drug Administration, which regulates manufacture, import and quality control of drugs in the country, is also inactive to put a stop to such unethical practices. Pharmaceutical companies practice drug promotion to boost sales and earn more profit, although it is clearly unethical, Prof Dr M Sharfuddin Ahmed, secretary general of Bangladesh Medical Association (BMA), told the news agency.Sharfuddin, also chairman of the Eye Department at Bangabandhu Sheikh Mujib Medical University (BSMMU), said Bangladeshi pharmaceutical companies produce standard medicines but all companies cannot produce quality products. According to the industry sources, the pharmaceutical companies allocate huge sums in their annual budget for gifts to be distributed among the Practitioners. Feedback from a number of representatives clearly indicates bribing. These could be a simple pen or even direct money for particular product. Also, chamber/room decoration, common household utilities, ornaments, showpieces, some doctors focuses on the money without having idea about product quality they are prescribing. A strict code of marketing is there but it’s violated often. The bribe value is higher in urban area than rural. Doctors have a competition to take transfer or absenteeism in their mandatories rather giving more time to their private settings in urban areas. Bangladesh Legal Aid and Services Trust (BLAST) working for strengthening the government regulatory bodies like Drug Administration, stressed full implementation of the Drug Act as well as effective inspection and monitoring on manufacturing, marketing and use of drugs⁽⁹⁾.

T. Crying Necessity of Pharmacovigilance:

I) Diethylene glycol tragedy in Bangladesh:

Diethylene glycol is a highly toxic organic solvent that causes acute renal failure and death when ingested. Its toxicity became apparent in the 1930s when it was used to prepare a sulphanilamide elixir in the United States. The deaths of at least 76 people from ingestion of this sulphanilamide elixir prompted the promulgation of the United States Food, Drugs, and Cosmetics Act in 1938, which regulates the evaluation and use of new drugs or foods. Diethylene glycol is occasionally identified in medical preparations or foods, though rarely in lethal concentrations. Drug toxicity due to formulation alteration is very much common. There are a lot of examples of this type of malpractices. It gets importance because of some recent incidence. In 2009, 26 children died due to formulation alteration in case of paracetamol syrup, where propylene glycol was replaced by diethylene glycol as a solvent. Health officials in the country said that so far 26 children aged between 11 months and three years have died after taking paracetamol (acetaminophen) syrup contaminated with diethylene glycol that was manufactured by local drug producer Rid Pharmaceutical Co (Arrest warrants issued after DEG kills 26 infants in Bangladesh). The trade name of the drug was Temset (paracetamol suspension). In addition, three hundred thirty-nine (339) deaths attributed to paracetamol syrup contaminated with diethylene glycol in 1990-1992. This incidence shows that, the formulation alteration by harmful chemical can pose a serious threat to health care system.

II) Substandard vitamin A tragedy in Bangladesh: Vitamin A deficiency may be a major threat to the health and survival of children and mothers. Effects of vitamin A deficiency extend much beyond blindness alone. Vitamin A deficiency increases the risk of child deaths from diseases such as measles and diarrhea. These infections contribute to over one-third of deaths among children aged 0-5 years in Bangladesh (UNICEF- Bangladesh media center, 6 June 2009). For this reason, the Government of People’s Republic of Bangladesh conducts National vitamin A plus campaign every year. In 2013 due to ingestion of substandard vitamin A capsule many children became sick, and online reports talked about some patients experiencing vomiting sensation and feeling unwell. Children were reported sick at Chittagong, Cox’s Bazaar and Lakhimpur among other places. Rumors of death were also reported with one report claiming a child had died from administration of Vitamin A capsule which were supplied by Indian source, Olive healthcare⁽¹⁰⁾.

III) Unethical drug promotion and their consequences:

Doctors are prescribing more Nitazoxanide instead of Metronidazole for amoebiasis and Azithromycin for diarrhea and PID. Benzodiazepines, sex hormones, steroids, Terbinafine, Butenafine, Crotamiton etc. Promoting Directly to Consumers through daily newspaper with separate advertising sheet on Dukoral (Swedish company) for diarrhea prevention. Other misused drugs are Diclofenac, caffeine with paracetamol, Irrational vitamin preparations with several minerals that are not detected by drug testing laboratories. But a mixture of 32 vitamins and minerals including selenium, vanadium, molybdenum, tin and many other unnecessary ingredients has been marketed in the country for a few years, violating the principles of the NDP. Spurious and substandard drugs are freely moving around the market. Aggressive promotion often leads to irrational prescriptions. So is applicable to counterfeit version of costly drugs that surface progressive mismanagement⁽¹¹⁾.

IV) Hospitals found selling counterfeit drugs, keeping expired reagents:

A mobile court of the Rapid Action Battalion or RAB has fined the Apollo Hospitals in Dhaka for selling in their pharmacy 30 types of counterfeit drugs and keeping expired reagents in its laboratory¹². A similar report was found with United Hospital, Gulshan 2, they were for use of expired reagent, selling unapproved drugs⁽¹³⁾. Seven employees including two fake doctors of Crescent Hospital of Dhaka’s Mohammadpur, were sentenced to different jail terms and penaltiesfor taking high charges from patients and providing fake medical reports¹⁴. Privately run clinics and diagnostic centers in Chittagong are rife with anomalies owing to a lack of proper monitoring. These clinics and centers often produce erroneous diagnostic reports that often lead the patients to serious health risks. A recent mobile court drive of the Chittagong district administration revealed that a reputed private clinic of the port city was running its operating theatre with expired medicine and reagents. Moreover, the assistant radiologist of the private clinic did not have any professional experience or academic qualifications. It has been alleged that most of the diagnostic centers are poorly equipped and lack modern laboratory facilities to conduct pathological tests. Technicians in these substandard private diagnostic centers often don’t possess the required qualifications to perform the tests properly, which can result in incomplete or inaccurate test results being filed. Consequently, patients lose their confidence in the test results provided by the sub-standard diagnostic centers. Seeing no other option, many resorts to going abroad and paying huge sums of money, which causes a loss for the Bangladesh economy¹⁵.During a visit to the Bangladesh Medical Association (BMA) market, EM Surgicals was found to store antibiotic disks for diagnosis in a refrigerator setting temperature beyond the recommended range in which such a product should be stored. This means that the diagnosis with those discs may not be accurate. Several shops of the same market were found selling expired insulin and reagents, namelyEM Surgicals, Bhuiya Surgicals, SA Surgical, Midland, Lotus and Atlanta Medica.A RAB unit raided two pharmaceutical distributors in Shyamoli on November, 2017 and found them selling large quantities of expired drugs and diagnostic reagents. None of them were stored at their proper temperatures, which caused denaturation; the warehouses kept no record of where and when they were manufactured⁽¹⁶⁾.

U. Contract manufacturing brings new hope for pharma companies:

Pharmaceutical companies are increasingly engaging in toll or contract manufacturing, a development that allows them to utilize unused capacities and reduce the need for fresh investment.Toll manufacturing, ushered in by the government in the National Drug Policy 2005, is an arrangement in which a company with specialized equipment processes raw materials or semi-finished goods for another company.Around 30 drug makers including Renata, Beximco and Popular are currently engaged in toll manufacturing for their local counterparts or even multinational companies, a sum which was less than 10 a couple of years ago.Contract manufacturing is gaining popularity as it creates a win-win situation for both parties.Currently, some foreign companies make a certain portion of their drugs for the domestic market through contract manufacturing, which lowers their operating costs.Contract manufacturing is mainly used for specialized or high-tech products, the facilities for which require considerable capital investment.It is unfeasible for a firm to develop facilities to make a single product.Insiders said the scope for toll manufacturing has enabled firms, especially the newly-established ones, to better utilize their capacities as they are yet to create a strong presence in the market.The system also becomes beneficial to those firms that do not have enough manufacturing capacity but register increased demand for drugs. To engage in contract manufacturing, pharmaceutical firms have to take approval from the Drug Administration⁽¹⁷⁾.

V. Emerging business of herbal medicines:

Herbal medicines are increasingly popular in local and global markets. More than 20 firms seek licenses to come into the sector. Herbal medicines are set to witness an investment boost as over 20 companies have lined up for licenses from the drug administration to manufacture such medicines to exploit business potentials in the sector, still almost untapped¹⁸.DGDA has received nearly two dozen of applications seeking approval to make herbal medicine. Of the applicants, four got licenses.The latest approval was given to Radiant Nutraceuticals Ltd, which is set to join the fray with three existing operators -- Square, ACME and Modern -- with Square Herbal and Nutraceuticals being the pioneer in the segment.Industry insiders said allopathic pharma market in Bangladesh is worth around Tk 4,000 crore, while the market size for herbal medicines including Ayurvedic and Unani stands at more than Tk 1,000 crore.Industry people observed that scopes to exploit the untapped herbal medicine now lure investors to the segment with majority of applications coming from new investors along with allopathic drug makers. The sector started pulling attention after the government had endorsed herbal medicine in the drug policy along with two other traditional branches of medicine -- Ayurvedic and Unani. Later the sector received a further boost as the government termed herbs and herbal medicine as one of the five priority sectors to diversify the country's export basket. Industry people observed that Bangladesh has prospect in making footsteps on the global market for medicinal plant and products as nearly 650 medicinal plant species have been identified to be in use in Bangladesh with around 25 plants having high value. Sector people said herbal medicine differs from Ayurvedic and Unani medicines due to its unique manufacturing process, although all the three branches of medicine depend mainly on medicinal plants. The herbal medicine market, which has been expanding gradually since 1980, will exceed Tk 2,500 crore by 2020, herbalists predicted. The sales volume of herbal medicines jumped to Tk 1,000 crore in 2010 against Tk 1 crore in 1980.The nation's 210 Ayurvedic establishments produce 272 types of medicines⁽¹⁹⁾.

W. MNCs facing a lot of problems:

In pharmaceutical sector, multinational corporations are more concerned about research and development than locally owned companies. The implication is that MNCs will need to find ways to increase their R&D productivity, and it also means that Indian and Chinese firms with relatively novel approaches to product and process development may find opportunities opening up for them, whether through go-it-alone strategies or through co-operative R&D partnerships with MNCs.Right after liberation war three fourth of the pharmaceutical industries was dominated by multinational companies. In view of the caliber of machinery and technical know-how which lies in their hands for producing importantand innovative drugs for the country, the task of producing antacids and vitamins will lie solelywith the national companies, leaving the multinationals free to concentrate their efforts and resourceson those items not so easily produced by smaller national companies. Multinationals will, however, beallowed to produce injectable vitamins as single-ingredient products⁽¹¹⁾. No multinational company without their own factory in Bangladesh will be allowed to market theirproducts after manufacturing them in another factory in Bangladesh on a toll basis.Multinational companies (MNCs) are allowed to manufacture all registered drugs except antacid and vitamins provided they have their own factories in Bangladesh. However, MNCs will be allowed to produce injectable vitamins because of higher technology. No foreign brands will be allowed to be manufactured in Bangladesh under third party license. Imports will not be allowed if similar products are manufactured locally. The impact of 82’ ordinance was dramatic. Total number of registered products both locally produced and imported from 122 foreign companies of 22 countries were 4340of which 1742 were found to be harmful, inappropriately formulated or therapeutically ineffective. Out of 1742harmful and /or ineffective drugs, 176 were imported and 949 were manufactured by 156 local manufacturers. Capitalist countries had exported more ineffective, useless or harmful drugs than that of socialist countries. West German and Swiss Companies ranked very high in mischiefs. However, these decisions kept MNCs on fire. The National Drug Policy (NDP) in 1982 and 2005 has major impact in the development and growth of the Bangladesh pharmaceutical industry. The need for NDP was very evident. Almost all the multinational companies were producing simple and non-essential drugs in Bangladesh like vitamins mixture or cough syrups. They used to import their raw materials from abroad at high prices. There was a need for vast quantity of essential, useful and economic drugs in Bangladesh. It was essential and important for Bangladesh to introduce a drug policy for the betterment of national health by availing international standard medicine in lower cost to Bangladeshi people. Precisely, multinational companies were prevented to reduce their unessential drugs production and discouraged to import raw material at high process. Under the Drug (Control) Ordinance 1982, the Government determines Maximum Retail Prices (MRP) of 117 essential drug chemical substances. This price determination is only for the local producer companies and still now the multinational organizations are determining their price by their own way. Many LDC countries have implemented full TRIPS patent protection or expanded TRIPS-plus patent protection in advance of the 2016 deadline. Activists say this is due to pressure from multinational pharmaceutical companies or developed country governments while MNCs say that IP laws are individual to each country and may reflect other trade and policy priorities. The role of multinationals in providing medicine for this country is acknowledged with appreciation. As NDP 1982 implemented, most multinational companies sold their business to local pharmaceutical. This fueled to the evolution of the local pharmaceutical sectors. According to the Directorate General of Drug Administration (DGDA) website, the value of the locally produced drug was 175 crores in 1981 that increased to 325 crores by 1985. Many multinational companies (multinationals) were dissatisfied with this development.GSK Bangladesh has convened a meeting next month as it seeks shareholders' nod to close its unprofitable pharmaceuticals business in the country.Meanwhile, nearly 200 employees of the local operations of the British multinational pharmaceuticals company have been staging a sit-in on the factory premises in Chittagong for the last 50 days to protest the closure decision.The demonstration began after the GSK Bangladesh board on July 26 proposed to shut down the plant, saying it was making losses²⁰. Earlier, Beximco completes Nuvista (formerly Organon) acquisition in a first for Bangladesh pharmaceutical industry²¹.Nuvista, formerly Organon (Bangladesh) Ltd, was a subsidiary of the Netherlands-based Organon International. It was sold out to the current Bangladeshi management in 2006.Phizer Bangladesh started its operations in 1972 as Pfizer (Bangladesh) Ltd. In 1993, Pfizer transferred the ownership of its Bangladesh operations to local shareholders and the name was changed to Renata Ltd (Renata LTD. Website). Sales of SK + F were worth Tk 1 crore in 1990 when it started its journey, a successor of Smith, Kline & French in Bangladesh, was acquired by Transcom in 1990.The company was renamed Eskayef Pharmaceuticals Limited²². In 1973, the UK based multinational pharmaceutical company, ICI plc, established a subsidiary in Dhaka, known as ICI Bangladesh Manufacturers Limited. In 1992, ICI plc divested its share to local management, and the company was renamed Advanced Chemical Industries (ACI) Limited⁽²³⁾. As part of the World Cancer Day, Apollo Hospitals Dhaka organized a rally jointly with Roche Bangladesh Limited and Sanofi Bangladesh Limited inside the Bashundhara residential area to increase awareness against the disease in the community⁽²⁴⁾. Both of these MNCs are facing potential competition in market and a negative sales growth every year, earlier faced by GSK Bangladesh as well.

X. High Court bans 34 pharmaceutical companies from producing medicines:

The order on Monday by Justices Syed Mohammed Dastagir and Ataur Rahman Khan came after hearing of a rule issued earlier on a petition filed by the Human Rights and Peace for Bangladesh (HRPB) to stop production and marketing of substandard medicines. The order asked the Bangladesh drug regulatory authority to regularly monitor whether these companies continued to produce and market medicines and file a report to the High Court after every four months.HRPB counsel Manzill Murshid said that the government has already cancelled the license of 7-8 of these 34 companies⁽²⁵⁾. The High Court has constituted a five-member committee to examine fresh application by those companies who have not had their license cancelled, if they agreed to abide by existing drug regulatory parameters.The committee consists of a representative each from World Health Organisation, Bangladesh Drug Regulatory Authority, Dhaka University's Pharmacy department and the Health Ministry.Twenty companies banned from producing all medicines namely Exim Pharmaceuticals, Avert Pharma Ltd, Bikalpa Pharmaceuticals Ltd, Dolphin Pharmaceuticals Ltd, Drugland Ltd, Globe Laboratories Pvt Ltd, Jolpa Laboratories Ltd, Kafma Pharmaceuticals Ltd, Medico Pharmaceuticals Ltd, National Drug Pharma Ltd, North Bengal Pharmaceuticals Ltd, Rimo Chemicals Ltd, Rid Pharmaceuticals Ltd, Skylab Pharmaceuticals Ltd, Spark Pharmaceuticals Ltd, Star Pharmaceuticals Ltd, Shunipun Pharmaceuticals Ltd, Today Pharmaceuticals Ltd, Tropical Pharmaceuticals Ltd and Universal Pharmaceuticals Ltd. Fourteen companies banned from producing antibioticsAd-dwin Pharmaceutical Ltd, Alkad Laboratories Ltd, Belsen Pharmaceuticals Ltd, Bengal Drugs and Chemicals (Pharma) Ltd, Bristol Pharma Ltd, Crystal Pharmaceuticals Ltd, Indo-Bangla Pharmaceuticals Ltd, Millat Pharmaceuticals Ltd, MST Pharma and Healthcare Ltd, Orbit Pharmaceuticals Ltd, Pharmic Laboratories ltd, Phoenix Chemical Laboratory Ltd, Rasa Pharmaceuticals Ltd and Save Pharmaceuticals Ltd^(26),(27).

Y. The PCB has revoked the registration examination system:

The PCB has revoked the registration examination system for the evaluation of graduate pharmacists for the issuance of Registration for Pharmacy practice. By dint of revoking examination, Pharmacy graduates from any public or private university would be awarded professional registration without any qualifying examination. To a new Pharmacy graduate this option may be seemed to be happy news because they don’t need to sit for any examination and they can get the certification for Pharmacy practice without any qualifying test. But practically this option may lead Pharmacy profession to challenge in the long run. The number of graduate Pharmacists coming out from private universities is 6 times greater than that of public universities. Recently, many intellectuals raised questions about the educational status and quality of some of the private universities although most of the private universities are doing pretty well. Whatever the private or public universities, the examination systems are maintained in all the developed countries like USA, UK, Canada, Australia, Japan, etc. on order to obtain the registration for pharmacy practice. So, what is the problem in our case? If the pre-qualifying examination is maintained, this will surely ensure the quality of Pharmacists suited for the practice of Pharmacy profession in Bangladesh. The examination system would enhance the ability of any graduate Pharmacist whether from private or public universities. At least they may learn/study many aspects of Pharmacy profession if they have to prepare for qualifying examination, that will help them to practice their profession. Therefore, at least a minimum evaluation test (that would ensure the basic and minimum knowledge of Pharmacy) must be conducted by the Pharmacy Council of Bangladesh before issuing professional registration for the practice of Pharmacy in Bangladesh. Obtaining registration after passing pre –qualifying evaluation will carry the dignity of graduate Pharmacists in their profession; otherwise registration will not have any evaluation in practical job markets⁽⁴⁾.

Z. Job crisis in the Pharmaceutical industries for the pharmacists:

Few years ago, students of pharmacy got job during final year of their bachelor degree. The number of pharmacy graduate increasing day by day. After that student finishing bachelor degree got job after the bachelor course. Now a days, number of pharmacy students became so high that even they are not getting job after their master degree. Besides, job sector for the pharmacist also increased but not sufficient. They are working in Product Development, Quality Assurance, Quality Control, Production, Marketing, Sales, Training, Regulatory Affairs, Commercial department etc. Few years ago, many pharmaceutical companies assigned chemist to perform laboratory work but now pharmacist start to replace chemist from pharmaceutical industry. Pharmacists are also working in veterinary industries. Today new job area for Bangladeshi pharmacist is Hospital Pharmacist and Clinical Pharmacist. Their working place is the hospital and deals with the patients and help the doctors to prescribe medicine. Thus, error in prescribing wrong medicine and miss-dose also reduced. New opportunity in another sector is cosmetic industry. Bangladesh is a land of medicinal plants. Thus, herbal medicinal industry also developing day by day. Some giant groups focusing their concentration in herbal industry. So, the demands of pharmacist in herbal industry are increasing day by day. Though food is one of the important parts of our daily life, one of the main causes of disease development is food habit. But pharmacist is not part of this industry. Pharmacist should develop their career in food industry. The pharmaceutical sector of Bangladesh has developed in the manufacturing of finished pharmaceutical products; the API and Excipients based industries have not yet remarkably advanced in this country. So, Bangladeshi Pharmacists have job scope limited to pharmaceutical finished products manufacturing industries. At present, industrial jobs also are saturated or will saturate soon. Therefore, getting entrance of new Pharmacists to Pharmaceutical Industries become quite tough or have narrow scope for new Pharmacists and also the problems to be faced for new pharmacist if having poor training, lack of in-depth knowledge of fundamental concepts and practical skills⁽²⁹⁾.No person shall manufacture any drug except under the personal supervision of a pharmacist registered in Register 'A' of the Pharmacy Council of Bangladesh: Provided that this provision shall not apply to the manufacture of any drug under the ayurvedic, unani, or homeopathic or biochemic system of medicine. Also, this act 13 (1) (Employment of Pharmacist) of the drugs (Control) Ordinance, 1982 (Ordinance No. VIII of 1982) was abandoned earlier by Government to create job opportunities for non-pharmacists.

Future Challenges:

· Lack of API Support:

API/Raw Material Production Plant: The major advancement of Bangladesh pharmaceutical sector has been occurred only in the production of finished products. Manufacturing of pharmaceutical products are vastly dependent on imported raw materials, as almost 90% of raw materials are now being imported. This dependency on imported raw materials is resulting in increased production cost of the finished products. Ultimately the competition to offer export prize is becoming tougher, which is one of the major challenges of pharmaceutical sector of Bangladesh. Setting up of a standardized Active Pharmaceutical Ingredient (API) plant is very essential. Local production of raw materials will greatly contribute to pharmaceutical export to extend export volume, and also can potentially contribute to the country’s economy.

· Bioequivalence Test Facility:

Bioequivalence study of a product is a must for the registration of that product in many of the moderately regulated and regulated countries of the world. There is no standard facility for bioequivalence study in Bangladesh. In order to register a product, a pharmaceutical company has to carry out this test in foreign country by spending of a huge charge. For this reason, many pharmaceutical manufacturers don’t show interest to register their products in foreign countries that require Bioequivalence study. It is relevant here to mention that BAPI and pharmaceutical exporters first felt the necessity of having Bioequivalence test facility in our country and they proposed and demanded to set up a modern Bioequivalence test center to the govt. for the promotion of pharmaceutical export.

· Modern Drug Testing Laboratory:

A major limitation of drug control authority of Bangladesh that also affects pharmaceutical export is unavailability of a modern, well equipped drug testing laboratory (DTL) with the engagement of sufficient and skilled pharmaceutical scientists. Due to lack of this, our drug control authority cannot monitor the quality of drugs manufactured by different pharmaceutical companies in Bangladesh. Moreover, foreign buyers and regulatory authorities raise question about the status of our drug testing laboratory, the central quality monitoring facilities of drug authority of Bangladesh.

· Regulated Markets:

To register pharmaceutical products in regulated markets it requires highly standardized documents. There are regulations directed by the regulatory authorities of United States of America, European Union, Australia and Japan along with other highly regulated and semi regulated countries. To meet all their requirements sophisticated and accredited manufacturing plant, standardized manufacturing process, proper quality control and above all highly skilled professionals are required. It is tough to meet all the requirements by small pharmaceutical companies of Bangladesh.

Recommendations:

The following g proposal may ease to Bangladesh pharma sector in reducing their complexities in different arena:

· The companies may offer better compensations to medical representatives to decline turnover

· Promotional cost curtailsthrough information-oriented knowledge-based promotion and avoid unethical cash or undue privileges. steps should be taken by all the companies together with a mutual understanding between them.

· The quality production should be ensured by the companies with better raw materials and excipients, which can help them to acquire a quality image in front of prescribers.

· Pharmaceutical companies should more export oriented, through several achievements (UK MHRA, TGA Australia certification).

· The same quality image should ensure the quality medicine to earn peoples’ confidence.

· They should stop violating the law imposed by the government, which can hamper the trust of the people of the country.

· Organizations should hire more foreign delegateson audits and observation to maintain highest standard.

· Government should impose more strict rules to abate the foreign pharmaceutical organizations to practice the concept of dumping in this country.Backward integration into APIscould reduce import cost.

· Providing incentive scheme by the govt. to the medicine exporters.

· International fair arrangement by Export Promotion Bureau (EPB) is a very effective way to bring more buyers and to establish business in a new horizon. More initiatives taken by BAPI (Bangladesh Association of Pharmaceutical Industries) like as before, high level pharmaceuticals delegation team visited foreign countries to explore export. This organization also demanded API Park, Bioequivalence test laboratory, Central drug testing laboratory, cash incentives, problems in remit transfer and sample sending etc. earlier.

· E-commerce is a new concept in Bangladesh. Again, trust and security issues in electronic money transaction and sensitive items like medical equipment and medicines are likely to provoke doubts in the customer minds⁽²⁹⁾. In this context, renowned pharma companies can have an option of ordering online in the already existing websites on a trial basis.

ACKNOWLEDGEMENT:

It’s a great gratitude and honor to be a part of healthcare research and education. Pharmacists of all disciplines that I have conducted was very much helpful in discussing pharmaceutical industry in Bangladesh, providing books, journals, newsletters and precious time. The greatest help was from my students who paid interest in my topic as class lecture and encouraged to write such article comprising features of pharma market, current situation scope, peculiarity and management in Bangladesh. Despite a great scarcity of funding this purpose from any authority, the experience was good enough to carry on research.

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Received on 10.10.2018 Modified on 03.11.2018

Asian J. Res. Pharm. Sci. 2019; 9(1):17-28.

DOI: 10.5958/2231-5659.2019.00004.3