Emerging Trends in Bulk Drug Industry

At the time of Independence the bulk drug industry in the country had a meagre investment of Rs. 10 crores, producing a few bulk drugs valued at only Rs. 26 crores.

Most of the bulk drugs and formulations were being imported from other countries. But now the industry has grown to proportions where investment has gone up to Rs. 1,000 crores and employment is provided to two lakh employees directly and an equal number indirectly.

Currently, the drug industry spends nearly 12% of its overall turnover on R & D. To compete with global competition, more emphasis should be laid on quality assurance, and that the Bulk Drug Manufacturers Association could act as the monitoring agency, providing a data bank for quality consciousness.

The Indian manufactures should focus their R & D efforts in the areas of diseases common to the Indian sub-continent, like abdominal, and respiratory tract infections. Manufacturers have tended to follow western R & D priorities which focus on cardiac and psychosomatic illness bearing little or no relevance on the Indian situation. The impact of rapid global changes has stimulated India to re-define its outlook so as to be in tune with the process of globalisation.

We are entering into an era of interdependence for faster growth in the international market and strategic alliances at national and international level will be needed. Universities and research institutions should build up liaison teams with the industry so as to provide a strong technological and infrastructural base. Indian bulk drug manufacturers should adopt a unified approach to ensure optimal utilisation of resources in development of infrastructural facilities, a congenial atmosphere for investment, and developmental thrusts in imbibing new technologies and marketing strategies.

Manufacturers should react to global changes and liberalisation in the Indian Economy. India is losing heavily to competition from China, and the government should intervene with R & D support.

Discovering a new drug takes 10 to 12 years and costs Rs. 200 million to reach the market. It needs the interaction of organic chemists and the departments of biology, biochemistry, toxicology, pathology and pharmacology.

India is the world leader in Ethambutol, Mebendazole, Ibuprofen, Metronidazole, Methyldopa and Sulphamethoxazole. There is scope for improvement in Vitamin A, B, B2, C, E, and B12. India needs to improve in fermentation products, penicillin and other antibiotics, plant derivatives and drug intermediates. There are future opportunities in synthetic steroids, semi synthetic penicillin and cephalosporous, beta blockers and other cardio-vascular drugs. India could also develop taxol and antimalarial drugs.

The Indian Bulk Drug Industry comprises of 600 manufacturing units spread over the country with an annual turnover of about Rs. 1,200 crores. Exports exceed Rs. 720 crores and the total investment in the industry is to the tune of Rs. 1,000 crores. It is heartening to note that due to liberalisation and incentives offered for exports, there is an increase of 43% in exports from 1-4-1992 to 31-12-1992 as compared to the figures of the corresponding period last year and hopefully the same trend will continue. Nearly 200 new licenses were issued in the recent past for the manufacture of bulk drugs involving an investment of Rs. 1,000 crores.

But the industry can achieve newer heights and better performance in the future provided certain hurdles which stunted its growth in the past are removed. The government needs to adopt a more pragmatic policy to remove impediments, clear certain anomalies, rationalise the duty structure and reduce unnecessary bureaucratic controls to help the industry achieve export targets. If this attitudinal change does not take place, pharmaceutical companies will discontinue additional investment in the industry.

In fact, in recent times, many pharmaceutical companies have diversified into other areas, due to the unremunerated pricing of drugs.
Before the new liberalised Industrial Policy was announced, the Bulk Drug Industry was almost delicensed and a mere SIA registration was required, in the post new industrial Policy scene, the Drug Industry came under compulsory Industrial licensing, thus effecting its growth.

The Drug Price Control Order is a big hindrance to the growth of the Industry. Due to a lack of price control on raw materials (which go into the manufacturing of Bulk Drug), the price of most Bulk Drug cannot be fixed. The prices of most raw materials/chemicals fluctuate on a daily basis effecting the costing of Bulk Drugs.

For most Bulk Drugs there is heavy competition internally as well as from external sources. In 90% of the cases, prices of the bulk drugs are at their bare minimum level and hence the control of prices under DPCO has no relevance. The DPCO should be totally scrapped and market forces should be allowed to determine the prices of Bulk Drugs.