The Union health ministry has started the process of strengthening of the drug regulatory systems in the states which play a vital role in implementing the provisions of the Drugs & Cosmetics Act in the length and breadth of the country. The ministry has now prepared a format of memorandum of understanding, that is required to be signed by the respective state government and government of India for implementation of the Rs.850 crore proposal of strengthening the states drug regulatory system.

Earlier on August 12, 2015, the Cabinet Committee on Economic Affairs had approved the proposal for strengthening of drug regulatory system both at the central and the state levels at a total cost of Rs.1,750 crore. Out of the total amount of Rs. 1,750 crore, an amount of Rs.900 crore will be spent on strengthening central structures and Rs.850 crore will be made available to the state governments, after signing a memorandum of understanding. Accordingly, the ministry has now prepared the format of memorandum of understanding.

The strengthening of the state drug regulatory system is important as under the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945, the manufacture, sale and distribution of drugs and cosmetics are regulated by the state drugs control authorities appointed by the state governments. Even sale of imported drugs after having been permitted by the Central Drugs Standard Control Organisation (CDSCO) is monitored and regulated by state drug control departments.

Presently, the drug regulatory systems in most of the states are faced with major concerns such as inadequate or weak drug control infrastructure at the state level; inadequate drug testing facilities; non-uniformity of enforcement of law and rules; lack of training to regulatory officials; lack of data base; and inadequate IT services.

According to officials, the Indian pharmaceutical industry, which is one of the most vibrant sectors of Indian economy, has been growing at the rate of 10-12 per cent per annum. It is the 3rd largest in the world by volume and 10th by value. The total size of the Indian pharmaceutical industry is about Rs.2 lakh crore, out of which exports account for nearly 55 per cent. To ensure the quality, safety and efficacy of medicines both for domestic use and for exports, the states regulatory system is required to be strengthened.