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The Central Drugs Standard Control Organisation (CDCSO) has initiated discussions among the stakeholders to address the discrepancy in approval of new drugs, where the first applicant has to bear exorbitantly higher cost to conduct clinical trial and bioequivalence (BE) study data while subsequent applicants spend considerably lesser cost for new drug approval. As per the New Drugs and Clinical Trials Rules, for approval of a new drug approved in another country, an applicant is required to conduct local clinical trials on the Indian population. The cost for a first-time applicant for new drug approval can be substantial, with estimates for full clinical trials ranging from $1 million to $3 million (approximately Rs. 8.8 to Rs. 26.4 crore) in India based on the complexity of the trials, while new drug development can cost Rs. 1.0-1.5 crore. Once the new drug is approved for the first applicant based on clinical trial and BE study data, the other applicants simultaneously submit the BE study report and obtain approval for the same new drug as subsequent application. As per the existing Rules, 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 BE study data. It was under this background, the central drug regulator decided to deliberate the matter with the stakeholders and the concerned departments for taking appropriate decisions to remove the discrepancy and to encourage the development of new drugs. By ending this discrepancy, the regulator wanted to formulate a balanced policy to ensure level playing field in new drug approval while fostering research and development (R&D) of new drugs in the country.
It is a fact that for approval of a new drug, the CDSCO normally receives applications from multiple applicants along with the protocol for conduct of clinical trials and BE study. After reviewing such applications in consultation with the subject expert committee, CDSCO grants permission to conduct the clinical trial and BE study with the new drug to multiple applicants. But, in most cases only one applicant actively conducts clinical trial and the BE study with the new drug and submit the reports to CDSCO for its approval. There can be no two opinions about the fact that 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 BE study data and the subsequent applicants who obtain approval of the same new drug based on BE study data only, for whom the cost of regulatory compliance is much lesser as they are not required to conduct the clinical trial. As this is the case, the opposition of a section of the industry against the initiative does not hold much water. A section of the industry argues that the drug regulatory authorities should be concerned about the safety and efficacy of the new drug only and not how much any pharmaceutical company spends. Therefore, present system should continue in the larger interest of patient community and the industry. Obviously, there is a regulatory gap in new drug approvals. This discrepancy imposes a disproportionate cost burden on first movers and creates a competitive disadvantage, potentially discouraging innovation and investment in new drug development. So, the Drugs Controller General of India has taken a good initiative as he wanted to remove the discrepancy and to encourage the development of new drugs. Now, the industry should cooperate with the initiative of the DCGI as it will ensure level playing field in new drug approval in the country.
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