Manufacture and trading in spurious and substandard drugs continues to pose a major threat to public health in India with total failure on the part of the Central and state authorities to check this illegal activity. No doubt, this is a massive task requiring suitable legislative measures and coordination of various law enforcement agencies. Unfortunately, no concerted action has been initiated by the Central government so far in this regard. An attempt was made by Union ministry of health in July 2001 to frame a broad based legislative mechanism to counter fake drugs by appointing a 13-member committee headed by Director General of Health Services with DCGI, chiefs of some of the state drug control authorities and representatives from industry associations. The committee was given three months time to take stock of the situation and recommend measures to build an effective national vigilance system. Nothing is known about this committee afterwards. Last year, Indian Pharmaceutical Alliance had undertaken a campaign to crack down spurious trade by organising search and seizure operations for its member companies. This initiative may have benefited the member companies of IPA to some extent. Last week, the drug control administration of Andhra Pradesh has appealed to retail chemists to get their stocks only from authorised distributors and asked the public to insist on bills when buying drugs. AP administration has also asked the print media not to accept ads that violate provisions of Drugs & Cosmetics Act. The move is in a bid to bring in some control to the trading in spurious and substandard drugs. These actions are certainly laudable but are isolated and cannot bring any major relief to this serious problem on a national scale.
According to an industry estimate, 15 percent of the drugs and pharmaceuticals sold in India are either spurious or substandard and the percentage is only growing with no effective check on this illegal activity. Increasing pressure of a powerful industry lobby on the government to allow certain drugs and cough preparations as OTC and the government's move to classify a set of ayurvedic preparations as food supplements may add a new dimension to the problem of spurious and substandard drugs in future. By permitting drugs for minor ailments as OTC and allowing them to be sold by stores other than medical shops, monitoring of their safety and efficacy will be almost impossible for state drug authorities just because of the huge number of such stores in each state. Similarly by classifying ayurvedic preparations as food supplements, they will come out of the ambit of control of drug control authorities. Many of the manufacturers are, already promoting these products as medicines with highly exaggerated claims. There is currently no law to effectively control such products and their promotion. Such liberalization of regulatory control at this stage can only embolden the spurious manufacturers to expand their activities aggravating the current situation. The government should, therefore, first bring some control on the growth of spurious drugs trade before thinking of liberalizing regulatory controls in this sector.