In a bid to strengthen the enforcement mechanism to control the proliferation and sale of spurious drugs in the country, the Union Health Ministry has proposed a ‘whistle blower scheme’ whereby the informer of manufacture of counterfeit or spurious drugs would be rewarded. The reward would constitute 20% of the cost of consignments, provided that the total compensation does not exceed Rs. 25 lakhs. The reward shall be given only when there is confirmation of the seizure of spurious drugs by the designated officers of Central Drugs Standard Control Organisation (CDSCO). The informer’s identity would be kept secret and it is expected that a reward so high would propel unearthing of the illegal activity. However, the proposal still awaits discussion with the pharmaceutical industry.

To ensure speedy trials for the reported cases of spurious drugs, the government also plans to set up designated special courts, as per the provisions of the Drugs and Cosmetics Act. The Drug Controller General of India is slated to be appointed as the nodal officer to oversee the functioning of the reward scheme. India still does not have any official estimate on the magnitude of spurious drugs prevalent in the market, hence a study to map the same is on the agenda.

The earlier efforts to contain the manufacture of spurious drugs include:

1. A proposal to set up a Central Drug Authority to centralize the administration of drug manufacturing activity on the lines of US Food and Drugs Authority, which would follow the Good Manufacturing Practice norms of WHO.



2. Proposed amendment in the Drugs and Cosmetics Act in 2008, to make provisions for spurious drugs and enhance penalties.

Currently, a new drug manufacturing application has to be made to the Drug Controller General of India and both the centre and the state governments are empowered to issue licences for manufacturing drugs. Central government lays down the legislative standards, clears new drugs, and supervises imports and exports; while the state government looks after manufacturing, sale and quality of drugs.

The Union Ministry for health wants to take the amendment Bill further and pass it into a law to make the regulatory mechanism robust. The problem of spurious drugs is beginning to reach alarming proportions and is creating hurdles for the Indian pharmaceutical industry in building up a reputation based on price and quality. While the US 301 Special Report in 2009 lauded the efforts of Indian Government in bringing forth amendments to Drugs and Cosmetics Act; it expressed concern over the magnitude of spurious drugs prevalent across the country. The international community is also wary of importing drugs from India in the wake of reports of mounting spurious medicines. African countries like Nigeria have been reported to be barring imports from at least 25 Indian pharmaceutical companies.

The propagation of spurious drugs is posing a serious threat to the regulatory set up as well as health administration. It is important that the drug regulatory system be improved as there is a high demand not only for domestic consumption; but also for export to developed and developing countries. Some poor countries with high burdens of disease have weak drug regulatory systems and import many HIV/AIDS, tuberculosis and malaria drugs from India.