What is the issue?
- Various new drugs and combination medicines that are currently available in the market haven’t got the necessary regulatory approvals.
- Drug Controller General of India (DGCI) has State regulators to review and recall such medicines immediately.
What did the recent directives come up?
- Recently, raids were conducted by the Central Drugs Standards Control Organisation (CDSCO) on some manufacturing plants in Uttarakhand.
- It emerged that 70 of the 118 products that were manufactured were without the DCGI approval, though they had been licensed by the State authorities.
- This was in contravention to law as new drug are not supposed to be manufactured without the approval of the central drug regulator.
- State authorities have been asked to not give manufacturing approvals for new drugs and combination medicines without DGCI consent.
What are combination medicines and what is their status?
- Combination medicines are ones that combine 2 or more dosages in fixed proportions in order to address illness that often accompany each other.
- Currently, even if Fixed Dose Combinations (FDC) of already approved drugs is to be released, it needs prior DCGI approval.
- Notably, the union government had also banned of 344 FDC Drugs in 2016 as they found them to be unsafe despite individual doses being safe.
- While the Supreme Court upheld the same in subsequent litigations, compliance wasn’t strictly forced on the pharma manufacturers by the states.
- Significantly, of 118 different FDC formulations sold in India between 2007 and 2012, it was found that only 43 were approved by the central regulators.
- It is to be noted that, the 118 FDC formulations were sold in over 3300 branded products made by about 500 different pharmaceutical manufacturers.
What is the way ahead?
- There are big risks for the society at large as unregulated dosages could affect patient health as well as promote drug resistance among microbes.
- Multinational companies were found to be manufacturing many unapproved formulations, despite pledging to tackle rising antimicrobial resistance.
- Drug resistance emerges as a result of erratic consumption of drugs that aid microbes to become immune to drugs and makes tackling illness tough.
- Hence, state regulatory authorities should ensure that they don’t approve any FDC drug without DCGI clearance and also ensure manufacturer compliance.
Quick Facts
Central Drugs Standard Control Organization (CDSCO):
- CDSCO is the national regulatory body for pharmaceuticals and medical devices in India.
- It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed.
- Drug Controller General of India (DCGI) is an organ of the CDSCO which is responsible for approving and licensing of drugs and medical devices.
- The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
Source: Business Line
