Centre mandates drug cos to submit post-approval changes for new drugs

Draft amendment seeks mandatory reporting of manufacturing and quality changes to drug regulator

In a bid to bring more transparency to drug regulation, the Union Health Ministry on Wednesday notified a draft amendment mandating the submission of post-approval changes (PACs) to the drug regulator for the import and manufacture of new drugs.

 

PACs refer to any alteration made by a manufacturer to an already approved drug or biological product relating to its manufacturing process, site, formulation, specifications or labelling.

 

In a gazette notification amending the New Drugs and Clinical Trials (NDCT) Rules, 2019, the ministry said the manufacturer or its authorised agent shall inform the licensing authority in writing in the event of any change in the manufacturing process, excipients, packaging, shelf life, specifications, testing or documentation.

 

“While informing the licensing authority in case of PACs is an industry practice, it was not mandatory by law for the import or manufacture of new drugs till now,” an official aware of the development told Business Standard.

 

The official added that the draft amendment now categorises PACs into three levels, in line with international practices.

 

“In case of any major quality change (Level I), the manufacturer shall obtain prior approval from the licensing authority, where the change has a substantial potential to have an adverse impact on the identity, strength, quality, purity or potency of a drug product,” the proposed amendment stated.

 

A similar requirement has been proposed for moderate quality changes, classified as Level II PACs, where changes may have a moderate potential to adversely affect product quality.

 

However, in the case of minor quality changes (Level III), manufacturers may implement the change without prior approval from the licensing authority, except in cases involving changes in the shelf life of the drug substance or drug product.

 

This exemption will apply only where the change has minimal potential to adversely affect the identity, strength, quality, purity or potency of a drug product. In such cases, an annual submission must be made to the licensing authority in the first quarter of every calendar year.

 

The Centre has invited objections and suggestions on the proposal from any person within 30 days.

 

“Objections and suggestions which may be received from any person within the period specified above will be considered by the central government,” the notification said.