For a country that has as many as 12,000 drug manufacturing units, there are just 1,500 regulatory staff in India, Dr V K Subburaj, Secretary, Department of Pharmaceuticals, said on Monday.
Speaking to Deccan Herald on the sidelines of a seminar on safe medicine here, Dr Subburaj said the staff who look into enforcement are only a handful. There are over 12,000 drug manufacturing units, 4,000 wholesalers, over seven lakh retailers in the country, according to the department’s statistics. “In the USA, there are about 3,000 manufacturing units and 15,000 drug inspectors. The drug enforcement system needs strengthening in India,” he said. Recently, the Union Cabinet sanctioned Rs 1,750 crores for strengthening the drug regulation mechanism. Dr Subburaj was of the opinion that with this, regulatory mechanisms would be strengthened as more number of posts will be sanctioned in the days to come.
“Procedural delay in recruitment is one of the factors that needs to be addressed. The country needs at least triple the number of regulators it has now,” he said. With Karnataka not having taken a call on the quota for disabled and the Hyderabad-Karnataka issue with regard to recruitments, appointments have not been carried out to even posts that were sanctioned long ago, according to top officials with the State Drug Control department.
The state has 85 sanctioned posts of regulatory officers. “About 50 sanctioned posts of drug inspectors are yet to be filled,” said State Drugs Controller, Raghuram Bhandari.
Drug inspectors are expected to ensure the Drugs and Cosmetics Act is being complied with, inspect medical stores and warehouses, check on the standard of drugs and have them analysed. They should also ensure appropriate action against offenders in case drugs are found to be substandard.
India manufactures drugs worth Rs two lakh crore out of which drugs worth only one lakh is consumed by the Indian market while the rest is exported.
In a country that has 12,000 manufacturing units, only 14 per cent comply with WHO standards. The rest meet Indian standards (Schedule M standard)
Even as there are rumurs that 30 per cent drugs in the market are spurious, officials from the Department of Pharmaceuticals state that it is less than 0.5 per cent.