The Ministry of Health is likely to approach the Supreme Court against the recent verdict of the Delhi High Court, which demanded the setting up of a high level expert committee to oversee the approval of new drugs in India. The ministry feels that the directive of the HC to have each fresh batch of drug cleared by the high-level committee is not practical.

At present, the designated officers in the Office of the Drugs Controller of India give new drug approvals. The court directive is to bring a change in this structure, thereby giving birth to a committee that would even have some members who are not attached to the department.

According to sources, the ministry would soon move the SC to quash the HC Order. The High Court has given three months time to the Health Ministry to form the high level committee with experts possessing impeccable integrity and eminence as its members.

Leaving the responsibility of the constitution of the committee to the Ministry, the court had indicated that the committee should comprise of doctors and other experts from with the drug regulatory system and outside.

The court wanted the committee to oversee the new drug sanctions and also ensure that the drug regulatory authorities are revalidating the quality of the drug every six months.

Delhi High Court has asked the Central Government to set up a high level committee within three months to oversee the approval of drugs in the country. While the Health Ministry has been given the task of constituting the committee, the HC wanted the government to ensure that no new drug approvals are taking place without the knowledge of the committee.

The HC directive came two weeks ago while disposing off a seven year old PIL by the People's Union of Civil Liberties (CW4622 / 1996) which had alleged that I V fluids bought by Safdarjung Hospital during 1993-94 were contaminated and had resulted in the death of four patients.

While delivering the judgement, the HC went on to suggest measures to strengthen the regulations to drug approvals and also to curb the manufacture and sale of spurious drugs.

The HC wanted the government to take strict legislative measures to ensure severe punishment for those involved in the business of manufacturing and marketing spurious drugs in the country. It wanted the Union Ministry of Health, Director General of Health Services and other authorities dealing with medical administration to ensure that the menace of spurious drugs is eradicated.

The court also had specific directions for law enforcing agencies. In case of death due to spurious drugs, investigations must be conducted on a priority basis by an officer of deputy superintendent of policy rank, the court said. The police and other agencies concerned were directed to conduct periodic raids on the suspected manufacturers and dealers of spurious drugs.