Bad medicine

Stronger laws and their effective implementation are necessary to check the worrying growth of spurious medicines

Akash Bisht and Sandeep Yadav Delhi

The ministry of health is worried. The spurious drugs' market in the country is burgeoning and health officials remain clueless on how to wage the battle. Conservative estimates peg the turnover in spurious drugs to Rs 6,000 crore. This ever-growing industry is a threat to health and demands suitable laws to stem the
illicit trade.

SK Arya, joint director, Indian drug manufacturers association (IDMA) holds weak laws, with loopholes, as the main cause of the flourishing spurious drugs business. 'People who indulge in the spurious drugs trade have all the right contacts and even if they are nabbed it is very difficult for the police to make a case against them because of the cumbersome procedure involved,' deplores Arya. The problem has also spilled across the border with Afghanistan, Nepal and Nigeria emerging as lucrative markets for spurious drugs made in India.

Economically, India's pharmaceutical industry is its strength, growing steadily at the rate of 10 per cent per annum for the last decade. Compared to a time when it was a net importer of formulations, it now exports most of them. In the boom, manufacturers of substandard and counterfeited drugs slip in.

They find a way through the rules and laws relating to the handling of spurious drugs, which are not in accordance with such large-scale production of medicines.

In the late 1990s, the supreme court, national human rights commission and members of parliament were continuously seeking tightening of the prevailing drug regulatory system. The government had already adopted several new policies and constituted multiple committees to keep a check on the increasing business of fake drugs. The new pharmaceutical policy approved by the cabinet laid stress on monitoring the quality of drugs. The Haathi committee suggested setting up a new drug regulatory authority. Then the Mashelkar committee, named after the director-general, council of scientific and industrial research (CSIR) RA Mashelkar, was formed and it recommended the establishment of a first class drug regulatory infrastructure and severe judicial action against those found guilty. The committee also suggested constituting special courts throughout the country to try spurious drug cases and to establish a network of informers. It further observed that a comprehensive review of the drugs and cosmetics act, not reviewed since inception and has been amended a few times, is mandatory. It advocated that a focused approach is required to amend the act from time to time to make it more effective.

Lack of appropriate legislative measures and poor coordination between various law enforcement agencies has helped the racket of spurious drugs. There have been numerous instances when media has reported seizure of large hauls of spurious drugs. These reports failed to grab the attention of the government.

When confronted with the issue of spurious drugs in parliament, the union health minister, Anbumani Ramadoss explained that to ensure efficient information exchange between drug regulatory officers in the country, in respect of licensing, sampling, prosecution, and so on, a countrywide computer networking project has been undertaken by the central government. He was sure that this would enable government to regularly monitor enforcement activities and recommend corrective measures. The minister said that the government plans to increase the number of drug testing facilities and upgrade the existing laboratories in assistance with the World Bank. Without further explanation, it remains elusive as to how these measures will resolve the problem.