The Indian Pharmaceutical Alliance (IPA) initiated discussions with the Central Drugs Standard Control Organisation (CDSCO) to regularise legacy medicines that have been marketed in India for decades but do not appear in the central regulatory database. The initiative aims to bridge historical documentation gaps while ensuring uninterrupted availability of essential medicines and strengthening regulatory compliance across the pharmaceutical industry. Representing 23 of India’s leading pharmaceutical companies, the IPA is working with the national regulator to establish a practical framework for integrating these long-approved products into the current central approval system.
Historical Licensing Practices Created Documentation Gaps
The issue traces back to India’s earlier drug approval framework, under which state drug authorities were responsible for licensing pharmaceutical products. Although these medicines were legally approved and marketed under state licences, many of the historical records were never fully migrated to the CDSCO’s central database. As regulatory systems evolved and central oversight increased, several well-established medicines were found to lack formal registration at the national level despite having been safely used for many years.
Among the affected products are widely prescribed medicines such as sodium valproate, used to treat epilepsy and bipolar disorder, carbamazepine, another commonly prescribed anticonvulsant, and certain strengths of lithium carbonate, which is used in the treatment of mood disorders. Several of these medicines are included in the National List of Essential Medicines (NLEM).
Increasing Regulatory Oversight Drives Compliance
The regularisation exercise comes at a time when India’s pharmaceutical regulatory framework is becoming more stringent. In recent years, the CDSCO has introduced several measures to improve transparency, traceability, and regulatory compliance across the sector.
These initiatives include the implementation of the ‘One Brand-One Formulation’ policy in July 2026, along with greater emphasis on maintaining comprehensive regulatory documentation for every pharmaceutical product marketed in the country. In addition, judicial interventions, including the Delhi High Court’s emphasis on the principle of “No Approval, No Market,” have reinforced the need for companies to ensure that all marketed products possess complete and updated regulatory records.
Compliance Costs and Operational Impact
The regularisation process is expected to require pharmaceutical companies to invest additional resources in regulatory compliance. Depending on individual product histories, manufacturers may need to retrieve historical documentation, compile technical dossiers, or generate supplementary data to satisfy current CDSCO requirements. Consequently, companies could experience temporary increases in regulatory and quality assurance costs as they update legacy product files.
Ensuring Continued Availability of Essential Medicines
While the documentation gaps primarily reflect historical administrative processes rather than product quality concerns, failure to regularise affected products could create regulatory challenges. In theory, medicines lacking complete central documentation could face restrictions or withdrawal from the market. However, since many of these products are classified as essential medicines, industry observers expect the CDSCO and pharmaceutical companies to adopt a collaborative approach that balances regulatory compliance with uninterrupted patient access.
What the Industry Will Watch
The pharmaceutical industry will closely monitor the government’s approach to implementing the regularisation programme. Clear regulatory guidelines, practical timelines, and streamlined documentation requirements will be essential for ensuring a smooth transition. For pharmaceutical companies, successful integration of legacy products into the CDSCO’s central database will strengthen regulatory certainty, improve compliance, and reduce future legal and operational risks.
As reported by whalesbook.com, the IPA’s initiative represents an important step towards modernising India’s pharmaceutical regulatory framework while safeguarding the continued availability of essential medicines and enhancing confidence in the country’s drug approval system.
