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 The Central drug regulator has initiated discussions among the stakeholders to address the discrepancy in approval of new drugs, where the first applicant has to bear higher cost to conduct clinical trial and bioequivalence study data while subsequent applicants spent much lesser for compliance.
The Central Drugs Standard Control Organisation (CDSCO), in a notice to the stakeholders on October 8, invited comments to ensure a level playing field in the new drug approval process in the country. The stakeholders have to submit their comments in 30 days from the issuance of the notice.
The feedback will help in formulating a balanced policy to ensure level playing field in new drug approval while fostering research and development of new drugs in the country, said Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI).
"... there is lack of level playing field between the first applicant who obtains approval of a new drug first time in the country based on clinical trial and bioequivalence study data and the subsequent applicants who obtain approval of the same new drug based on bioequivalence study data for whom the cost of regulatory compliance is much lesser as they are not required to conduct the clinical trial," said the regulator.
"In order to remove the discrepancy and to encourage the development of new drugs, it has been decided to deliberate the matter in consultation with the stakeholders and the concerned departments for taking appropriate decisions," it added.
As per the New Drugs and Clinical Trials Rules, 2019, for approval of a new drug approved in another country, in general, the applicant is required to conduct local clinical trials in the Indian population. However, there are certain provisions under the rules under which local clinical trials may be waived.
For approval of a new drug, many a time, CDSCO receives applications from multiple applicants along with the protocol for conduct of clinical trials and bioequivalence study.
CDSCO after reviewing such applications in consultation with the SEC grants permission to conduct the clinical trial and bioequivalence study with the new drug to multiple applicants.
In many such cases, it has been observed that only one applicant actively conducts clinical trial and the bioequivalence study with the new drug and submit the reports to CDSCO for its approval.
Once the new drug is approved for the first applicant based on clinical trial and bioequivalence study data, the other applicants simultaneously submit the BE study report and obtain approval for the same new drug as subsequent application.
Under the present regulations, once a new drug has been approved for the first time in India, subsequent applicants seeking approval for the same drug are not required to conduct clinical trials. Approval for such subsequent applicants is granted based on chemical and pharmaceutical data and bioequivalence study data.
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