The Central Drug Standards Control Organisation regulates the clinical trials for drugs and medical devices in India. Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country (Read About – How to market your products in India). The Rules 122A, 122B and 122D, 122 DA, 122DAA, 122E of Drugs and Cosmetics Rules and Annexure A, B, C and D of Schedule Y, describe the information/data required for approval of clinical trials and/or to import or manufacture of new drug for marketing in the country.
The CDSCO Offers four New Updates to Promote Clinical Research. While the government has taken several steps to bring clinical trials at par with global practices three major components still have to be improved – ethical committees, investigators and clinical sites – have to be brought up to desired standards. For this, training and attitudinal changes are needed. Dr Gupta, while speaking on the subject, ‘current status of clinical trial norms in India’, opined that tough regulatory norms and their strict compliance were needed in clinical trials for better patient care and to allay public fears with regard to unethical practices. “While robotic clinical trials are in the news, they can never replace human trials. May be we can reduce a few of the human clinical trials in certain areas,” he said. READ ALSO: Documents required for Clinical Trials in India.
If a drug is taken off the market in two or more countries on grounds of safety and efficacy, they must be pulled out of the Indian market immediately and inform the CDSCO of the same. Waiver of clinical trial will be more stringent and restricted only in cases of national emergency, orphan drugs for rare diseases and conditions which currently stand untreated.
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