Tracking down spurious drug manufacturers is becoming increasingly difficult to the drug administration in the country with increasing number of drug manufacturing units and retail outlets. There are more than 20, 000 manufacturing units and five lakhs of medical stores spread across the country. It is almost impossible for the drug administrations of states to check every strip of drug sold in the retail market.

According to M Venkateswaralu, Deputy Drugs Controller-General, Western Region, Mumbai, it's a big racket in the unorganised sector involving hundreds of crores of rupees. It is difficult even to attempt a guess on the turnover and the number of drugs involved. Although exact estimates are not available, a sizable number of spurious drugs are pushed to unsuspecting consumers by unscrupulous elements.

He said the drugs were categorised into spurious (with no drug ingredients), sub-standard (with some drug ingredients) and counterfeits (imitation of popular brands with identical drug ingredients). Most of the counterfeits had the same formulations and efficacy as that of the original popular brands. It was difficult to differentiate between the fake and the original.

The drug control department had been conducting raids regularly and hundreds of cases had been booked. Once the case goes to the court, it takes its own time for prosecution. These cases do not come under the purview of the Drug Act, but treated as economic offences. The punishment includes cancellation of the licences, fine and jail up to five years.

Venkateswaralu was presenting a paper on “ The Healthcare Industry – Drug Control Perspective” at the Asian Symposium on Healthcare Industry in Hyderabad. Although healthcare industry comprises of various segments like drugs and pharmaceuticals, medical devices, hospitals, diagnostic labs and personnel hygiene products, only pharmaceutical industry came under regulatory controls. Even in this case, a large majority of the drug units were in the unorganised sector, making it difficult to track down the illegal ones.

Tracing the growth of the healthcare sector in the country, Venkateswaralu said in the post-independence era, the country totally depended on imports of drugs. The pharma industry in India began to take shape only in 1965-66 and since then it had an impressive track record of growth. By the year 1995, the country became almost self-sufficient in the manufacture of APIs as well as formulations. Not only that the country was initiated into drug discovery research and contract manufacturing and research by the turn of the millennium.

He said due to pressure on healthcare costs many countries would be looking to affordable and good quality generics. In the US alone, over 43 per cent of the total prescriptions were written for generics. The generic market in the US and European countries would provide abundant scope for accelerating India's exports. It was estimated that the global market for generics could be around $ 80 billion by 2007. Undoubtedly, the growth potential for the Indian pharmaceutical industry to penetrate in the global market was vast and could be tapped effectively.

There was also tremendous opportunity for marketing formulations and APIs to registered and un-registered markets, marketing of neutraceuticals and herbal drugs, opportunities in collaboration and joint ventures and discovery research.

To meet the global standards, the industry must develop credibility on the data generated in contract research, improve communication and logistics, improve transparency, upgrade allied industry (machinery for manufacturing, packaging, packing materials, supply of containers, closures etc), besides computerisation and validation of computer systems.