Some of the industry experts have expressed opposition to the Central Drugs Standard Control Organization (CDSCO)’s recent notice to seek consultation, feedback and comments on the cost of regulatory compliance spent by the first applicant or pharmaceutical company for a new drug approval and the subsequent applicants or companies for the same new drug.
While opposing the notice, these industry experts, who do not want to be named, have argued that the drug regulatory authorities should be concerned more about the safety and efficacy of the new drug than how much any pharmaceutical company spends on the regulatory compliances for approvals.
Therefore, they argue, present system should continue in the larger interest of patient community and the industry. They also added that this may also impact drug affordability and accessibility as companies will be forced to spend time and money on compliances not required.
This comes in the wake of the CDSCO notice dated October 08, 2025 towards removing the discrepancy in terms of huge cost of performing clinical trials and bioequivalence (BE) study borne by the first applicant for new drug approval as against the subsequent applicants. As per the existing norms, subsequent applicants can obtain approval of the same new drug based on only the BE study data at a far lesser cost.
As per the New Drugs and Clinical Trials (NDCT) Rules, 2019, for approval of a new drug approved in other country, in general, the applicant is required to conduct local clinical trial in the Indian population. However, there are certain provisions under the rules under which local clinical trial may be waived.
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.
BE studies are significantly less expensive, with an application fee of around Rs. 2 lakh in India, because they only need to demonstrate that a generic drug is equivalent to the original or innovator drug. The total cost depends on factors like trial phase, drug type, and patient sample size.
Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI) in the notice stated that there is lack of level playing field between the first applicant who obtains approval of a new drug for the first time in the country based on clinical trial and the subsequent applicants who obtain approval of the same new drug without the clinical trial.
The DCGI further stated, “This notice is intended to initiate discussion among the stakeholders to arrive at a broader consensus. All the stakeholders are requested to provide their comments//suggestions on the subject at dci@nic.in and snd@cdsco.nic.in. This window of opportunity will close within 30 days.”
Dr Raghuvanshi further explained, “For approval of a new drug, many a time, the CDSCO receives applications from multiple applicants along with the protocol for conduct of clinical trial and bioequivalence study. The CDSCO after reviewing such applications in consultation with the Subject Expert Committee (SEC) grant permission to conduct the clinical trial & bio-equivalence 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.”
The DCGI further stated that 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. Thus, 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 trial. Approval for such subsequent applicants is granted based on chemical and pharmaceutical data and BE study data.
Source : Pharmabiz
