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: The recent development of a tie-up between the US Food and Drug Administration (FDA) with its Indian counterpart, following the visit of Union health minister to the US, is of great significance. According to reports, the FDA will help Indian drug manufacturers to reach standards applicable in the US. This will open doors into one of the largest drug and cosmetics markets of the world for Indian companies, particularly SMEs. India has the highest number of manufacturing plants approved by US FDA (61 plants), which is next only to that in the US.

The Indian pharmaceutical industry is undergoing fast- paced changes, though not without pains. It has more than 24,000 companies: big, medium and small. Of these, around 300 are in the organised sector, around 16,000 in the SSI sector and the remaining have very small operations. The smaller companies are already reeling under the June 30 deadline for implemention of mandatory Good Manufacturing Practices (GMP) under Schedule-M of the Drugs and Cosmetics Act. SSIs cite lack of resources as a key reason for their inability to upgrade to prescribed standards. Barely 1,000 SSIs would have geared themselved up for meeting the deadline. But there seems little option. Further, the government is establishing a National Drug Authority, an independent body on the lines of the Telecom Regulatory Authority, which will further tighten the quality and process standards for the drug industry.

The industry produces about 60,000 finished medicines and roughly 400 bulk drugs, used in the formulations. India is one of the top five producers of bulk drugs in the world. Pegged at $6 billion, the domestic market is not growing enough, but the international market is extremely promising. As reported in Scrip World Pharma News(UK), India ranks 4th in the world, accounting for 8% of world’s drug production by volume and 1.5% by value, but still ranks 17th in terms of export value of bulk actives and dosage forms. Exports have been growing by 30% per annum during the past 5 years, and constitute almost 40% of the total production in India. This is to be further triggered by the fact that generics worth over $40 billion are going off patent in the coming few years, which is close to 15% of the total prescription market of the US.