With global regulatory agencies, especially the US and the UK, banning drugs from India citing manufacturing lapses, the government is ready to dole out a set of stringent standards for pharmaceutical companies.
The Centre has prepared a WHO-GMP compliant checklist for drug manufacturers and inspectors. Any deviation from the checklist during inspections are likely to attract penalties, which could be double of what are being slapped currently.
GMP refers to good manufacturing practices.
Recently, the World Health Organisation (WHO) issued a number of warnings over clinical practices at domestic drug manufacturing plants.
“The government has identified flaws in the drug regulation regime ranging from inadequate drug-testing facilities, lack of database to lack of training of regulatory officials,” GN Singh, Drug Comptroller General of India (DCGI), told HT. “Any fault with execution will lead to heavy penalties, which are likely to be 50% to 100% more than the current ones,” he said.
At present, deviations currently attract a fine of Rs 10,000 to Rs 10 lakh. Other penalties include ban on export for 15 days, issuance of warning letters or cancellation of licences.
The government has called a meeting of state regulators on October 16 to finalise the plan.
While companies did not respond to mails from HT, the industry body welcomed the move.
“The government should heavily penalise if any deviation is found. The only condition is that the penalty should be transparent and stringent,” said DG Shah, secretary-general, Indian Pharmaceutical Alliance, which represents Dr Reddy’s, Lupin and Sun Pharma, among others.
A network of efficient drugs testing laboratories are also likely to be established to assess the risk component of the drug safety.
Moreover, the government is also likely to issue a list of mandatory deliverables, which would need to be adhered to by the states. “The review of the entire project would be carried out every three months by the central government,” Shah said.