Drug regulators get a shot in arm!
Among the various steps taken to strengthen the regulatory institution, the Union Health Ministry has created 216 additional posts in Central Drugs Standard Control Organization (CDSCO) since 2008. The Central Drugs Testing Laboratories have been provided new sophisticated testing equipment. Two sub-zones of CDSCO (Hyderabad and Ahmedabad) have been upgraded to full zones and three new sub-zones (Bangalore, Chandigarh and Jammu) have been created. Besides this, the scheme of regular overseas inspection of manufacturing facilities situated abroad has been initiated to ensure proper compliance of good manufacturing practices guidelines before registering them for import of drugs. Two such inspections have already taken place in China.
The National Pharmacovigilance Program has been launched to capture Adverse Drugs Reactions (ADRs) for safe-guarding public health. 60 ADR Monitoring Centers are already functioning besides the National Coordination Center at the Indian Pharmacopoeia Commission, Ghaziabad (UP) and a Pharmacovigilance Cell at CDSCO headquarters.
According to the information provided by Minister for Health and Family Welfare, Mr Ghulam Nabi Azad in the parliament on March 08, 2013, "The state governments have also been requested to strengthen their manpower and infrastructure. On its part, the central government has been extending financial assistance to them for upgradation of their infrastructure under the National Rural Health Mission. Further, during the 12th Five Year Plan, it has initiated a new scheme for providing financial assistance to the states/ UTs for strengthening of State Drug Control Departments."
The quality of drugs, whether generic or non-branded or branded manufactured or imported for sale in the country is regulated under the provisions of the Drugs and Cosmetic Act, 1940 and the Drugs and Cosmetic Rules, 1945. Under these laws, the manufacture and sale of drugs are regulated by the state governments and the import, approval of new drugs and banning of drugs are regulated by the central government through CDSCO.