Question : MECHANISM TO CHECK FAKE DRUGS MANUFACTURE

(a) whether the Government proposes to set up an effective mechanism to check and detect manufacture of fake drugs; and

(b) if so, the details thereof?

THE MINISTER OF HEALTH AND FAMILY WELFARE(SHRI GHULAM NABI AZAD)

(a) & (b) : The Central Drugs Standard Control Organization (CDSCO) under Ministry of Health and Family Welfare is continuously writing to the State Drugs Controllers for providing the full details on the manufacturers of the spurious drugs along with their names and address and action taken to prevent movement of spurious drugs in the market. The issue of import of spurious drugs was also taken up by CDSCO with Department of Revenue Intelligence, Customs authorities and all port officials to have harmonized action throughout the country to curb such imports.Other measures taken to check the menace of spurious drugs are given below:

1. The Drugs and Cosmetic Act has been amended vide Gazette notification dated December 2008, to increase the penalty and punishment of spurious drugs manufacturing.

2. A Committee has been formed in 39th Drugs Consultative Committee (DCC) to look into the problems of spurious drugs in the country.

3. In order to assess the extent of spurious drugs in the country,a country wide Survey has been undertaken by the Ministry of Health and Family Welfare through Central Drugs Standard Control Organization (CDSCO).

4. Under the Capacity Building Project through World Bank, assistance has been provided to upgrade testing facilities and to establish new drug testing laboratories so as to enhance the capacity of the laboratories to test large number of samples.Under this project 23 States and 6 Central Drugs Laboratories have been strengthened through renovations, extensions and equipments.

5. Schedule M to the Drugs and Cosmetics Rules, 1945, pertaining to good Manufacturing Practices was amended to make it at par with the International standards and it is mandatory for the manufacturers of drugs to comply with the requirements of this Schedule for quality control of the drugs manufactured by them.

6. Detailed guidelines have been issued to the State Governments to undertake focused surveillance over possible movement of spurious drugs.