India is preparing one of the largest regulatory audits in the history of its pharmaceutical sector, with the government planning to verify every drug approval issued since 1945 and reconcile decades of missing records.
The initiative, led by the Central Drugs Standard Control Organisation (CDSCO), aims to create a comprehensive database of medicines whose approvals are either absent or incomplete in the country’s central regulatory repository. Manufacturers will be required to submit historical approval documents to authenticate medicines that were cleared by regulators but never fully recorded in the official database.
The exercise addresses two long-standing gaps in India’s drug regulatory system. The first involves medicines and fixed-dose combinations approved by the Drugs Controller General of India (DCGI) that do not appear in the CDSCO’s approvals database. The second focuses on drugs approved by state licensing authorities before 1988, when India lacked a centralized framework for tracking new drug approvals.
Before the Drugs and Cosmetics (Eighth Amendment) Rules came into force in 1988, individual states could independently license new formulations and dosage strengths. Since records were maintained manually and often remained with individual state authorities, many approvals were never consolidated into a national repository.
According to government documents, these gaps create uncertainty for regulators, manufacturers and healthcare professionals. Without complete historical records, authorities face challenges in verifying the regulatory status of older medicines and determining whether they continue to meet current safety and efficacy standards.
Officials say the audit is intended to strengthen regulatory oversight rather than question the legality of medicines already available in the market. By asking manufacturers to submit historical approval documents, the CDSCO plans to authenticate legacy approvals and integrate them into a single verified database.
The initiative follows the recent launch of India’s upgraded Drug Registry, which contains data on more than 123,000 branded medicines, 10,000 generic medicines and 29,000 pharmaceutical substances. Officials believe combining this registry with a reconciled approval database will improve traceability, reduce regulatory ambiguity and create a single source of truth for approved medicines in India.
The exercise also reflects the broader challenge of modernizing regulatory systems that were built long before digital record-keeping became standard. As India’s pharmaceutical industry has grown into one of the world’s largest, regulators are now attempting to reconstruct more than eight decades of institutional records to ensure future oversight is based on complete and verifiable information.
If completed successfully, the audit would mark the first comprehensive effort to document every centrally and state-approved medicine since India’s drug regulatory framework was first established in the mid-1940s.
Source: Mint
