New Delhi: India is preparing to launch a massive trace-and-track exercise to identify missing drug approvals from its central repository, amid concerns that decades-old formulations not meeting current safety and efficacy standards may still be in circulation.
The initiative aims to resolve discrepancies in the Central Drugs Standard Control Organisation’s (CDSCO) database and create a comprehensive repository of missing drug approvals over the past 81 years, including legacy licences dating back to 1945 when the country’s drug laws were first enacted, according to three government officials and documents reviewed by Mint.
“It has been observed that certain drugs and fixed dose combinations (FDCs) approved by CDSCO are not reflected in the official approvals database maintained by the CDSCO. This discrepancy creates confusion for State Licensing Authorities (SLAs), manufacturers, and healthcare providers, as the absence of updated records may lead to misinterpretation of regulatory status,” the government document reviewed by Mint stated.
India's pharmaceutical industry is primarily governed by the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. They regulate the manufacture, import, distribution, and sale of drugs across the country.
The plan is to update records for drugs approved by the country's top drug regulator—Drugs Controller General of India (DCGI)—that are missing from its database, alongside medicines licensed by state authorities before 1988, the officials cited earlier said, requesting anonymity.
The plan, discussed late last month during a meeting chaired by the Drugs Controller General of India Rajeev Singh Raghuvanshi, and attended by state drug controllers, will require manufacturers to provide proof of permissions to eliminate market confusion and ensure patient safety.
The move assumes significance given that the absence of a central tracking framework makes it difficult to verify if these older formulations meet modern safety metrics. Before 1988, India did not have a central system to track or approve new drug combinations, which allowed individual states to grant manufacturing permissions on their own without the central regulator ever knowing about it.
"Before 1988, there was no definition of a new drug, and product permissions were granted strictly by state authorities. Because early drug manufacturing was entirely manual and only matured after the 1960s when most companies came in, neither CDSCO nor the states possess complete historical records. CDSCO is now attempting to compile a de facto data bank for these pre-1988 formulations till 1945 when the drug rules were implemented,” said the first government official.
The exercise comes in the backdrop of health and family welfare minister Jagat Prakash Nadda on Monday launching the new version of India’s Drug Registry to standardize medicine-related information across the country, comprising over 123,000 branded, 10,000 generic and 29,000 substances.
Queries emailed to the spokespersons of the health and family welfare ministry and DCGI office on Monday remained unanswered.
The overhaul targets two primary loopholes that complicate oversight for state regulators, manufacturers, and medical practitioners. The first part addresses the drugs including fixed dose combinations (FDCs) approved by CDSCO but not reflected in CDSCO approvals database. The second component addresses pre-1988 legacy drugs and combinations approved independently by states but entirely missing from CDSCO drug tracking system.
The government document seen by Mint stated that prior to 1988, State Licensing Authorities issued licences independently, especially with reference to new strengths and new dosage forms of the approved molecules, without centralized oversight.
“Presently no consolidated database exists to track such products. As a result, these drugs may still be in circulation without central validation, posing challenges for regulatory monitoring and raising concerns about their compliance with current safety and efficacy standards,” the document stated. “To address this issue, it is proposed that a reconciliation exercise be undertaken by the CDSCO by asking the manufacturers to submit a copy of such approvals along with supportive documents for its authentication so that the approval database may be updated accordingly for transparency and better clarity.”
“The national drug database contains missing entries because around 20-30 years back, drug approvals were manually recorded by different officers over the decades, leading to accidental omissions and poor data tracking over time. Under the current data-cleansing framework, the central regulatory authority is calling upon pharmaceutical manufacturers to submit copies of old state-issued and central clearance certificates alongside supporting files to rectify and update the missing information," a second official said.
The industry welcomed the move.
Viranchi Shah, national spokesperson for the Indian Drug Manufacturers Association (IDMA), representing around 1,200 member companies, said, “This is an important exercise to update the list of drugs that were approved before 1988. Because records were maintained manually by individual states at that time, a unified repository does not exist. Although efforts have been made by CDSCO to create a repository, there exists some gaps that span back decades. The data collection will require manufacturers to retrieve verification records for drugs approved as far back as 1945 when the drug law was first made.”
On 21 September 1988, the government introduced the Drugs and Cosmetics (Eighth Amendment) Rules, 1988, by inserting Part XA into the then Drugs and Cosmetics Rules, 1945. This amendment established clear procedures for importing and manufacturing new drugs, including requirements for clinical trials, and data submission among others under the drug rule.
“A validated and reconciled database will improve traceability of approvals, strengthen regulatory oversight, support evidence-based decision-making, reduce discrepancies in historical records, and enhance alignment between CDSCO and State Licensing Authorities," said Sheetal Arora, promoter and chief executive officer, Mankind Pharma Ltd. "We believe this initiative represents an important step towards strengthening regulatory data governance, improving the reliability of India's pharmaceutical approval records, and creating a single source of truth for approved pharmaceutical products."
Experts favoured the need for a comprehensive drug database.
“This centralized database did not previously exist. In February 2023, a regulatory brainstorming session in Hyderabad with state and central controllers identified key limitations in our drug infrastructure. One of the primary recommendations was the need to establish a centralized database of all drugs and formulations approved across the country over time. No single repository previously tracked varied strengths or combinations approved independently by separate regulators at different times. This will help regulators evaluate new therapies and allow doctors to verify if a medicine holds valid approval,” said former health secretary Rajesh Bhushan.