Innovation with Caution in New Clinical Trial Rules

• The Indian government has streamlined the drug approval process through the New Drugs and Clinical Trials (NDCT) Rules, which reduced timelines and clarified safety procedures.

• The Drugs Controller allowed novel products to enter the Indian market without local clinical trials if they had been approved in the US, UK, Australia, Japan, Canada, and the EU.

• The Union Ministry of Health and Family Welfare has proposed amendments to the NDCT rules, including waiving the local clinical trial requirement for more formulations.

• The government should ensure the safety of clinical trial participants and the welfare of patients.

• Regulatory processes continue to be the Achilles’ heel of pharma innovation in India, with complex documentation, clinical trial, and inspection processes.

• Developing synergies between laboratories in the country and outside its shores could help address these problems.

• Medical policymakers should heed the caveats of abbreviating trials, as new formulations that manipulate genetic material or modify immune cells carry long-term risks.

• The government has invited public comments on the amendments to the NDCT rules, but must patiently parse criticisms and observations.

Ethical Trial Regulations is important topic for Civil service exam (WBCS).

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