The Office of the WHO Representative to India has expressed concern over the incorrect use of WHO references with regard to the volume of spurious drug manufacture in India. The WHO representative has stated that there is no actual study by the organization, which concludes that 35 per cent of World's spurious drugs are produced in India. Recent media reports had quoted the CII Taskforce members' as having projected this figure based on the so-called "WHO study".
In a communication to the Drugs Controller General of India, the WHO representative also hoped to issue an official clarification in this connection.
It is felt that the source of this figure is a commentary in 2001 made by an Indian journalist in the Lancet.
The letter stated that Indian pharmaceutical market, with annual sales ranging between US $ 7-8 billion, ranks third in the world, and the majority of Indian pharmaceuticals are produced by large manufacturers according to WHO Good Manufacturing Practices.
Noting that no country is immune from the threat of counterfeit drugs, the letter appreciated the Government of India for having initiated this year the Food and Drugs Capacity Building Project with a long-term aim to improve the quality and safety of foods and drugs in India.
In an attempt to analyse the actual size of spurious drug manufacturing in India and to suggest measures to counter the problem, the government has recently appointed an expert committee.
The expert committee under the chairmanship of Dr R A Mashalkar had, in its interim report, recommended for stringent penal actions against spurious drug manufacturers. In it proposed amendment to Drugs and Cosmetics Act, the committee had suggested death penalty or imprisonment for a term of life or not less than 10 years with fine of rupees one lakh upto three times the value of the goods seized, which ever is higher for manufacture or sale of such drugs.
Under the provisions of Drugs & Cosmetics Act, 1940 and Rules there under, the responsibility for regulating manufacture and sale of drugs including monitoring their quality is vested with the State Governments. The State Governments are advised from time to time to gear up their enforcement machinery to detect and unearth spurious/fake drugs moving in the inter-state commerce to provide and strengthen their regulatory infrastructure and to establish their own State level testing labs.
The State Governments have also been advised to keep strict surveillance over the suspected dealers; collect survey samples under National Survey Quality Evaluation of Drugs (NSQED) programme; constitute/reactivate state drug advisory committees in which various trade and industry association as well as consumer associations can file representations; establish separate intelligence-cum-legal cell; develop efficient communication facilities and recall procedures and engage experienced counsel for fighting spurious drug cases etc.