NEW DELHI: Seeking to cash in on the demand for cheap Indian drugs abroad, the government has decided to upgrade drug testing facilities in the country to the standards of the US Food and Drug Administration to facilitate better exports. Health Ministry sources said that though Indian drugs have a huge market in African and Latin American countries, exports to the US and the European countries were suffering as medicines sometimes don’t meet their norms.
Sources said that till now the focus of Indian drug testing was on the final products but now facilities and procedures used for manufacturing them would also be checked.
The guidelines for manufacturing practices were issued by the Drug Controller General of India. The guidelines are proper water facilities, rodent control mechanism focus on separate manufacturing facility, among others.
The inspections are being carried out jointly by Central Drugs Standard Control Organisation (CDSCO) officials and state drug inspectors. “By 2017 end, we plan to complete inspections of all pharma firms in the country,” a source said. The inspections will assess the compliance of manufacturing facilities with the checklist and other Good Manufacturing Practices and also seek to harmonise the procedures for conduct of inspection throughout the country.
While Andhra Pradesh and Karnataka adhear better to manufacturing norms, Bihar and Uttar Pradesh regulators show major lack of knowledge, officials said.