To make the approval procedure even faster, manufacturers of drugs can start the process of clinical trials or bioequivalence studies by making a prior “intimation” to the drug regulator, instead of obtaining its “permission” that was earlier required.
The process to approve the formal application will be completed within 45 days, instead of 90 days now. These changes to the New Drugs and Clinical Trials Rules will come into effect in March, according to a notification published on Tuesday.
To manufacture new drugs or investigational new drugs for analytical and non-clinical testing (excluding sex hormones, cytotoxic, beta lactam, biologics with live microorganism and narcotics and psychotropic drugs), companies can submit an online application and start manufacturing them based on the acknowledgment of the intimation.
Govt reduces timeline to review applications for drug trials by half; only intimation needed
Change in Rules
According to industry experts, these changes will accelerate manufacturing of new and investigational drugs. These will also help exports, making it easier and less time-consuming.
Currently, manufacturers need to take permission form the drug regulatory authority before manufacturing a new drug or an investigational new drug to conduct clinical trials or bioequivalence study.”In the sub-rule (1), for the words ‘ninety working days’ wherever they occur, the words ‘forty-five working days’ shall be substituted,” the notification said.
“Earlier manufacturers were supposed to take permission by applying in Form CT-10 to the Central Licencing Authority to manufacture such new drugs or investigational new drugs…It was time consuming. The change will be of significant help,” said an industry insider.
The health ministry had last year invited suggestions and objections on the same issue. The responses were reviewed by the government and after consultation with the Drugs Technical Advisory Board (DTAB), India’s top drug advisory board decided to amend the New Drugs and Clinical Trials Rules, 2019.
“These rules may be called the New Drugs and Clinical Trials (Amendment) Rules, 2026,” said the notification. “In the marginal heading, for the word “permission”, the words “permission or prior intimation” shall be substituted”, it said.
