Indian drug regulator may scrap licence renewal; move may affect quality of medicines

By Prabha Raghavan, ET Bureau | October 8, 2016

NEW DELHI: India’s drug regulator proposes to scrap the renewal of licences and approvals for manufacturing and selling drugs and cosmetics in the country as part of efforts to remove hurdles and improve the ease of doing business, moves that some experts said would affect the quality of medicines.

Provisions of the Drugs & Cosmetics Rules of 1945 are being revisited to consider if the validity of licences and approvals can be made perpetual, the Central Drugs Standard Control Organisation (CDSCO) said in a notice dated October 6. It also proposes a similar system for laboratories that test drugs.

The licences and approvals can be made perpetual provided they are not cancelled or suspended by the licencing authority, according to the notification.

For industry, this change would remove the need to periodically renew licences for the manufacture, sale and distribution of products. Right now, drug companies are required to renew the licences to sell their products every five years.

“However, there should be assessment of compliance with the conditions of licences/approvals at least once in 10 years,” GN Singh, the Drugs Controller General of India, said in the notice to state drug regulators and pharma industry associations.

The CDSCO is also considering upgrading Good Manufacturing Practices to make them at par with the World Health Organization’s guidelines, according to the notice. The regulator has sought comments, suggestions and inputs on the proposed moves by October 21.

Scrapping of licence renewals would be a step back in upholding patient interest, said Leena Menghaney, ?South Asia regional head of the Access Campaign at Médecins Sans Frontières. According to her, the proposed gap between compliance assessments is too long and renewing of licences needs to be implemented properly instead of being scrapped.

“It is already clear that manufacturers have been de­facto enjoying licences in perpetuity. The CDSCO, as seen in the court cases surrounding the revocation of marketing approval for irrational fixed dose combinations, finds it very difficult to revoke them even on grounds of public health,” said Menghaney. “Licences should be renewed and it should not be merely a renewal on paper through payment of fees.”

At the time of renewal, it is important to address all information pertaining to good manufacturing practices and the source of active pharmaceutical ingredients used to give the drug its therapeutic effect and any other variation that the manufacturer may have implemented, she added.

However, GMP consultant Ranjit Barshikar said there would be no detrimental effect on public health and the quality of medicines. “(The licences are) no doubt perpetual, but there will be assessment once in 10 years for licencing compliance. This doesn’t mean that DCGI will not do GMP inspections,” he said.

The Indian Pharmaceutical Alliance, Indian Drug Manufacturers’ Association and the Organisation of Pharmaceutical Producers of India did not immediately respond to phone calls and emails from ET seeking comment.

The government is said to be planning a major overhaul of the country’s drug policy, with moves that include scrapping the need to renew manufacturing licences and easing regulations to allow medical and drug research here. The numbers of drugs under price control has also been brought up as part of this discussion.

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