The Union Ministry of Health and Family Welfare is likely to propose a comprehensive amendment to Drugs and Cosmetics Act 1940 to the Union Cabinet soon. The major amendment sought, apart from the plans for the autonomous Central Drugs Authority of India (CDA-I) would be in the area of export of drugs. The amendment would seek inclusion of specific clauses with respect to quality of drugs exported from the country.

According to official sources, the proposal for the inclusion of export related norms in D&C Act would be part of the annexure that accompanies the cabinet note being prepared for the new, autonomous CDA-I. "The formation of CDA-I needs an amendment to the Act. Instead of bringing about that single amendment, we thought of bringing a comprehensive change in the Act. The major change is related to drug export as the D&C Act, as on today, has no mention about exports. This happened because we were not a drug export country and was importing almost all the medicines we required at the time of framing the D&C Act. Situation has just reversed and India is a major drug exporter today. We need the change to be reflected in our Act to ensure better regulatory standards for drug exports", sources informed.

Interestingly, the draft cabinet note prepared by the ministry has already passed the scrutiny of the legislative department of the Law Ministry. It now needs an approval from Law Ministry's legal department now. Officials said that the legal department clearance is expected this month itself. Once it is vetted by the Law Ministry, it would be placed for Cabinet approval, it is learnt.

As reported earlier, the CDA (I) is envisaged as an autonomous body on the lines of United States Food and Drugs Administration (US FDA) that will report to the Health Ministry. This would mean Central Drugs Standard Control Organisation (CDSCO) being taken out of the ministry control for all practical purposes. The authority will have full powers to make appointments to the vacancies, retain the revenue it collects as fee and fine and also decide upon the procedural norms to be followed by the authority.

The central authority would be allowed to charge for its various services and retain the fee it collects and utilize for improving the efficiency of drug regulatory activities in the country. The CDA (I) would also gradually become the sole authority for the issue of drug manufacturing licenses. As per the current plan, the shift towards centralization of manufacturing licenses would be carried out in a phased manner.

The structure of CDA (I) is more or less similar to what has been recommended by the Mashelkar Committee in its report on drug regulatory issues. It is to have 10 main divisions to independently handle issues like regulatory affairs and enforcement, new drugs and clinical trials, biological and biotechnology products, pharmacovigilance, medical devices and diagnostics, imports, organizational services, training and employment, quality control affairs and legal and consumer affairs.

The government is expecting to clear all procedural hurdles and have CDA (I) in place by year end.