The Union Ministry of Health and Family Welfare has issued a draft notification proposing significant amendments to the New Drugs and Clinical Trials Rules (NDCTR), 2019, aiming to streamline regulatory procedures and reduce approval timelines for clinical trials and new drug manufacturing.
The draft has proposed to reduce the approval timelines for clinical trials and related permissions from ninety working days to forty-five working days to accelerate the regulatory review process.
In addition to streamlined timelines, the draft proposes to insert a proviso after sub rule (2) of rule 52, stating, “Provided that in case of manufacture of new drug or Investigational new drug for analytical and preclinical testing (excluding the new drug and Investigational new drug of category of sex hormones, cytotoxic, beta lactum, Biologics with live microorganism and narcotics & psychotropic drugs) an online application shall be submitted as notification and applicant can manufacture such drugs based on the notification.”
The amendments also include a revision to Rule 52 of the existing rules, clarifying that manufacturing of new drugs or investigational new drugs for clinical trial purposes must be preceded either by formal permission or by notification to the Central Licensing Authority.
The ministry has invited all stakeholders, including pharmaceutical companies, academic researchers, and members of the public, to submit their views on the proposed changes within 30 days of draft published.