The Central Drugs Standard Control Organisation (CDSCO) has initiated a comprehensive review of India's new drug approval framework, seeking stakeholder feedback to address significant disparities in the regulatory process between first-mover applicants and subsequent market entrants. The move is expected to have major implications for India's ₹3.4 lakh crore pharmaceutical industry, where innovation-driven firms have long sought greater policy support to offset the high costs of clinical trials.
Regulatory Imbalance Creates Unequal Competition
Under the current New Drugs and Clinical Trials Rules, 2019, applicants are generally required to conduct clinical trials on Indian patients before marketing a new drug. However, CDSCO has identified a critical flaw in the implementation: once a new drug is approved in India based on local clinical trial data from one applicant, other companies can seek approval for the same drug by submitting only bioequivalence (BE) study data, bypassing the need for full-scale clinical trials.
The notice, issued by CDSCO's Subsequent New Drugs Division, highlights that in practice, only the first applicant usually bears the cost and regulatory risk of generating clinical and bioequivalence data. "This has led to a lack of a level playing field between the first applicant, who conducts local trials, and subsequent applicants, who obtain approvals based only on bioequivalence study data," CDSCO stated in its notice.
CDSCO noted that when multiple applicants submit protocols for clinical trials and bioequivalence studies, often only one applicant actively conducts the clinical trial and submits reports for approval. Once the new drug receives approval based on this data, other applicants simultaneously submit BE study reports and obtain approval as subsequent applications, with significantly reduced regulatory requirements and lower compliance costs.
Industry Impact and Innovation Concerns
Industry observers indicate this imbalance discourages domestic firms from taking the lead in clinical research. "The economics do not add up for first movers," said a senior R&D head at a leading Indian pharmaceutical company. "Once you spend crores conducting a local clinical trial, competitors can enter soon after with minimal data requirements and lower costs. It disincentivises true innovation."
The regulatory disparity creates a situation where subsequent applicants seeking approval for the same drug are not required to conduct clinical trials, with approval granted based solely on chemical and pharmaceutical data and bioequivalence study data. This results in much lower regulatory compliance costs for follow-on applicants compared to the pioneering companies that invest in comprehensive clinical development programs.
Policy Reform Initiative
To bridge this gap, CDSCO has called for public comments within 30 days, aiming to "deliberate the matter in consultation with stakeholders and concerned departments for taking appropriate decisions." Stakeholders can submit feedback via dci@nic.in and snd@cdsco.nic.in.
The regulator emphasized that feedback would be used to formulate a balanced policy "to ensure a level playing field in new drug approval while fostering research and development of new drugs in the country."
Strategic Timing and Future Implications
Experts note the timing of this consultation is significant, coming as India seeks to position itself as a global hub for drug discovery and clinical trials under the government's "MedTech and Pharma 2047" vision. A more equitable regulatory regime could encourage companies to invest in novel drug pipelines rather than rely primarily on generic replication.
"India's policy framework must evolve from being generics-centric to innovation-supportive," said a pharmaceutical policy analyst. "A transparent system that rewards first movers without compromising on affordable access could catalyse investment in R&D and position India competitively against global innovation hubs."
If CDSCO's review leads to stronger recognition for first applicants through data protection, market exclusivity periods, or differentiated regulatory pathways, it could realign incentives across the domestic industry. However, regulators face the challenge of striking the right balance between encouraging innovation and maintaining timely access to affordable medicines, especially in therapeutic areas of high public health importance.
The consultation marks one of CDSCO's most direct engagements with the pharmaceutical industry on reforming approval norms in recent years. Depending on stakeholder feedback, the agency could propose amendments to the New Drugs and Clinical Trials Rules or issue clarificatory guidelines that redefine how new drug applications are treated, signaling a broader policy shift toward a fairer, more competitive regulatory environment.
