The first meeting of the high power inter-ministerial committee headed by Dr. R. A. Mashelkar, director-general of Council for Scientific & Industrial Research (CSIR) is to commence on February 26, 2003. The meeting, called by the ministry of Health and Family Welfare to discuss all issues pertaining to spurious drug manufacturing and present drug regulatory mechanism, is to be attended by representatives of drug industry, trade, consumer organizations, scientists and officials from all concerned ministries. The committee was announced a month ago and is to submit its report within six months.

The committee is to suggest concrete and time bound measures for strengthening and upgrading the drug regulatory infrastructure. The pharmaceutical industry is expected to lobby for strict legal provisions to counter the movement of spurious drugs. Possibilities of setting up a National Drug Authority, with a mandate for centralized drug licensing, is to be explored by the committee.

As per the Drugs and Cosmetics Act 1940 and Rules made there under, the responsibility to ensure manufacture of quality drugs and to check possible movement of sub standard drugs rests primarily with the State Governments. The infirmities in the present enforcement system and lack of focused strategy to preclude any possibility of manufacture and sale of spurious or fake medicines is resulting in the presence of spurious drug products in the supply chain. The committee will discuss the complexity involved in combating the crime and also seek measures to strengthen the vigil at the state level.

A review of the corresponding penal provisions in addition to making these offences cognizable under the provisions of Drugs and Cosmetics Act is to help drug enforcement authorities in obtaining speedy police assistance, which is very critical to apprehend the criminal elements involved in such clandestine activities. The Mashelkar Committee is to look into these possibilities.

The industry associations who are part of the committee would also attempt to prompt the government for a legislation that would hold the dealer also responsible for the presence of spurious drugs in the supply chain. Inclusion of mandatory registration of packaging material supplier as one of the conditions for issue of manufacturing license would also be discussed.

The Health Ministry has taken a number of initiatives like streamlining the licensing procedure for manufacture and sale of drugs, new import registration procedures for all drug products, revised bench marks for Good Manufacturing Practices (GMP), computerization and networking of all central and state drug control offices and drug testing laboratories in the country to ensure safety efficacy and quality of drugs as well as to harmonize regulatory requirements with the changing global practices. The Ministry is also in the process of taking up a capacity building project to augment the drug testing facility in the country so that about one lakh samples can be tested annually as against the present figure of about 38,000 samples and also to reduce the time of testing to less than one month.