Pharma firms likely to get ‘perpetual’ licences
The government is close to finalising a proposal to grant licenses in perpetuity to pharmaceutical companies, scrapping the existing policy that required renewal of licences every five years.
Aimed at enhancing the ease of doing business in India, the government has proposed that manufacturers be granted licences that will remain valid as long as they comply with the Good Manufacturing Practices (GMP).
India’s drug regulator has also proposed a periodic inspection of drug manufacturing plants every three years by both central and state inspectors to verify compliance with the conditions of licence and provisions of the Drug and Cosmetics Act, 1940. The suggested changes in the existing Drugs and Cosmetic rules will soon be sent to the law ministry for vetting after which they will be notified.
“We are in the process of promoting self regulation but at the same time strict action on violation will be taken,” said GN Singh, Drug Controller General of India (DCGI)
For drug makers, the amendment would mean doing away with the need to periodically renew licences for the manufacture, sale and distribution of products.
“It has been proposed that manufacturing and sale of licenses once issued shall remain valid forever unless suspended or cancelled by the licensing authority. Non-compliance to GMP would immediately attract cancellation. The relevant rules will be amended for this purpose and will then be notified,” a senior official at the Drug Controller’s office said, requesting anonymity.
Fearing that joint inspections would cause delays in the licensing procedure and make compliance a lengthy affair for pharma firms, earlier industry lobby had approached the country’s drug regulator suggesting that a single authority should carry out inspections.
However, the government has decided to go ahead with carrying joint inspections. The good news for the industry is that the inspection will be carried every three years instead of annually as earlier recommended in the proposal. In case the company makes any changes in the manufacturing process, a no-objection certificate from the regulator will be mandatory, said the official.