Pharmaceutical Industry

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Pharmaceutical Industry is one of the most developed high tech sectors in Bangladesh. It is contributing a lot in the economy of the country. After the promulgation of Drug Control Ordinance 1982, the development of this sector was accelerated. The growth was observed at a considerable rate in the last two decades. The professional knowledge, thoughts and innovative ideas of the Bangladeshi pharmacists working in this sector are the key factors for this development. Due to recent development of this sector we are exporting medicines to global market including European market. This sector is also providing about 97% of the total medicine requirement of the local market. Leading Pharmaceutical Companies are expanding their business with the aim to expand export market. Recently few new industries have been established with high tech equipments and professionals which will enhance the strength of this sector.

In Bangladesh there have 252 licensed pharmaceutical companies at present in total including nationals and multinationals. Presently the national companies account for more than 75% of the pharmaceutical business in Bangladesh. However, among the top twenty companies of Bangladesh, six are multinationals. These multinational companies are channeling into and marketing almost all the life saving imported products and new innovative molecules in Bangladesh. Multinational and large national companies generally follow current Good Manufacturing Practices (GMP) including rigorous quality control procedure of their products. The Drug Act of 1940 and its rules formed the basis of the country's drug legislation. Unani, Ayurvedic, Homeopathic and Biochemic medicines were exempted before, but now they are under the control of drug legislation. A good percentage of poor and ethnic people of Bangladesh are depended on such traditional systems of medicine. At present there have 268 Unani, 201 Ayurvedic, 09 Herbal, 79 Homeopathic and Biochemic licensed manufacturing units. They are produced medicines worth of about Tk 2 billion. Even in the allopathic market there were extemporaneous preparations dispensed from retail and hospital pharmacies, as per prescription made by the physicians.

The pharmaceutical industry, however, was much neglected during the pakistan regime. Most multinational companies had their production facilities in West Pakistan. With the emergence of Bangladesh in 1971, the country inherited a poor base of pharmaceutical industry. For several years after liberation, the government could not increase budgetary allocations for the health sector. Millions of people had little access to essential life saving medicines. With the promulgation of the Drug (Control) Ordinance of 1982 many medicinal products were considered harmful, useless or unnecessary, and was removed from the market creating availability of essential drugs to increase at all levels of the healthcare system. Increased competition helped to maintain prices of selected essential drugs at a minimum and affordable level.

In 1981, there were 166 licensed pharmaceutical manufacturers in the country, but local production was dominated by eight multinational companies which manufactured about 75% of the products. There were 25 medium sized local companies which manufactured 15% of the products and the remaining 10% were produced by other 133 small local companies. All these companies were mainly engaged in formulation out of imported raw materials involving an expenditure of Tk 60 million in foreign exchange. In spite of having 166 local pharmaceutical production units, the country had to spend nearly Tk 30 million on importing finished medicinal products. A positive impact of the Drug (Control) Ordinance of 1982 was that the limited available foreign currency was exclusively utilised for import of pharmaceutical raw materials and life saving finished drugs, which were not produced in the country. The value of locally produced medicines rose from Tk 1.1 billion in 1981 to Tk 1.690 billion in 1999. At present, about 97% of the total demand of medicinal products is met by local production. The local companies increased their share from 25% to 75% on total annual production.

At present the national and multinational companies are manufacturing about 19,830 brands of medicines under 1081 generics in different dosage forms. There were, however, 2000 wholesale drug license holders and about 80,000 retail drug license holders are involved in drug distribution and dispense in Bangladesh. Anti-infective is the largest therapeutic class of locally produced medicinal products, distantly followed by antacids and anti-ulcerants. Other significant therapeutic classes include Non-Steroidal Anti-Inflammatory Drug (NSAID), vitamins, cardiovascular drug, Central Nervous System (CNS) and respiratory products. A most remarkable progress the local industry has made in recent time is the phenomenal increase in the local production of basic chemicals. Presently top pharmaceutical companies in Bangladesh are also in the process of getting into bulk drug production with collaborative technology, technology transfers and joint venture basis. At least 21 companies are produce about 41 active pharmaceutical ingredients (API). The large-scale players in the Bangladesh pharmaceutical industry currently include Square Pharma, Beximco Pharmaceuticals, Nib Chemicals, Ganoshastha Pharmaceutical, Opsonin Chemicals, ACI Pharmaceuticals, Globe Pharmaceuticals and others. The basic chemicals include Paracetamol, Ampicillin Trihydrate, Amoxycillin Trihydrate, Cloxacillin, Diclofenac Sodium, Aluminium Hydroxide Dried Gel, Magnesium Hydroxide dried gel, Dextrose Monohydrate, Hard Gelatin capsule shell, Chloroquine Phosphate, Propranolol Hydrochloride, Benzoyl Metronidazole, Ciprofloxacin Hydrochloride, Cephradine, Pyrantel Pamoate, and others. However, most of these are confined to the last stage of synthesis. To feed the local industry, more API industries are needed. The recent approval, as was reported in a section of the media, to a 30 billion dollar API industrial park in Munshiganj will inject fresh momentum to the pharmaceutical industry. Bangladesh can save at least 70% of expenditure on raw materials when the API part goes into production. At present Bangladesh imports 80% of its pharmaceutical raw materials. A good number of skilled professionals from home and abroad are expected to join the industry to enrich its human resources pool.

Bangladesh pharmaceutical industry has potential to grow and compete in the international market. Its ability to comply otherwise with the guidelines of quality assurance provides it the competitive advantage. Most companies follow the Good Manufacturing Practice (GMP) standards, set by the UN World Health Organisation (WHO). Bangladesh can compete with countries like India, China, Brazil and Turkey in the international export market due to its quality compliance, if the country is fully able to enjoy the exemption limit until 2016 under the provisions of the World Trade Organisation (WTO) with regard to generic, patients and other related matters as least developed country (LDC). The ability of the Bangladesh industry is otherwise undisputed about achieving excellence.

The current Good Manufacturing Practice (GMP) is recognised worldwide for its holistic approach to ensure the quality of food and pharmaceutical products. With its firsts growing pharmaceutical export, Bangladesh now exports a wide range of major therapeutic products like capsules, syrups and tablets. The country exports high-tech specialized products like hydrofluoroalkane (HFA) inhalers, suppositories, steroids, oncology products, immunosuppressants, nasal sprays, injection and large volume IV infusions. The local pull of demand for medicines set the industry in a second footing. The industry produces quality medicines for millions of people in Bangladesh. Almost self-reliant in pharmaceutical products, the industry meets 97% of national demand for medicines.

The combined capacity of the industry for the pharmaceutical formulation is huge and a number of companies have recently got approval from UNICEF as its global as well as local supplier of pharmaceutical products. Full GMP compliant facilities have been developed to meet the regulatory requirement of any country in the world. A good number of Bangladeshi companies have won accreditation for export from the regulatory authorities in some developed countries. The accreditation will allow them to enter the export market with their competitive prices and standards. They are now international players. Bangladesh drug policy requires all its pharmaceutical manufacturers to strictly comply with the standards. The investment has helped the companies get certification from the international regulatory bodies. Bangladeshi companies are now in a position to export pharmaceutical products to any part of the globe. Besides, out of the total domestic requirement of medicines almost 97% is met by the local manufacturing and Bangladesh also exports to the foreign countries around the world. The current turnover of the industry in Bangladesh is about Tk 55 billion. The export value of pharmaceuticals, though small, is growing at 50 per cent per year. Exports increased from $8.2 million in 2004 to $28.3 million in 2007 and expanded further in last two and half years. The export destinations have now risen from 37 to 72 countries during the period. Presently Bangladesh exports pharmaceutical medicine to USA, India, China, Taiwan, Hong Kong, European Union, Singapore, Malaysia, Pakistan, Sri Lanka, Thailand, Burma, Bhutan, Nepal, Yemen, Mauritius, Vietnam, Kampuchea, Laos, Mexico, Columbia, Ecuador, Russia, Uzbekistan, Tazakistan, Kenya, Tunisia, and Maldives as well as to the least developing countries where there is hardly any industry for the production of pharmaceutical formulations.

The primary responsibility for drug quality control lies with the manufacturers. However, the government's Drug Testing Laboratories (DTL) and the Directorate General of Drug Administration (DGDA) have the monitoring and supervising role. There are two government drug-testing laboratories. DTL at Dhaka is in the Institute of Public Health and the regional DTL at Chittagong both is under DGDA. Drug administration is responsible for registration of drugs for marketing in Bangladesh and for inspection of premises and licensing. With its present set up and inadequate strength, DGDA often finds it difficult to carry out its very large volume of assigned work. The national drug policy and the regulatory control policies are yet to achieve best results for a healthy growth of the pharmaceutical industry. Because of the limited capacity of the government's drug testing laboratories, the quality of products manufactured locally cannot be uniformly ensured. Restrictions on patent rights discourage foreign investors to come up actively in the pharmaceutical market in Bangladesh. Introduction of new research molecules is difficult due to slow registration process and restrictions on patent protection. Presently the government is actively reorganizing the Department of Patent, Design and Trademarks under the Ministry of Industry through employment of new staffs in the regulation of patent rights and related matter. So that the foreign investors may feel interested to invest in Bangladesh. Although the fixed mark-up system of pricing help in keeping the prices of pharmaceutical products low, this made it difficult to cover costs of marketing and distribution. The fixed mark-up system also discourages some companies to invest for GMP and assurance of high quality production. The products that are studied for bioequivalence and measured its safety through clinical trail in comparison to innovator products, the regulatory authority should consider the price fixing of such products also. This will motivate the pharmaceutical manufactures in practicing the standard quality procedures.'

Bangladesh has a large generic market, and companies such as Square and Beximco are beginning to have success overseas. However, despite the country possessing huge manufacturing capabilities, the complete lack of Research and Development (R&D) in domestic companies could cause the market to stagnate. Very few pharmaceutical companies have product development department. No collaborative research exists between university and industry. For future development such link between Industry and University is mandatory. The National Drug Policy of 2005 was a great step forward for Bangladeshi pharmaceutical industry. [Sitesh Chandra Bachar]