Old drugs under review for quality control, efficacy
The Government’s firm stance signals that even long-established drugs must now prove their safety and effectiveness under modern scrutiny
New guidelines bring Indian manufacturing standards in line with World Health Organisation (WHO) Good Manufacturing Practices (GMP) norms.
In a decisive move to strengthen drug safety and regulatory oversight, the Government is conducting a comprehensive review of 13 commonly used medicines that have been in circulation for over three to four decades.
These drugs, originally approved under older regulatory frameworks, are now being reassessed to ensure they meet modern scientific and safety benchmarks. The initiative, spearheaded by the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organisation (CDSCO), is a critical step towards improving drug regulation in India.
Pharmaceutical manufacturers have been directed to submit detailed data on these drugs, including clinical trial results, adverse effect reports, and efficacy studies. This initiative aligns with India’s larger goal of modernising its regulatory framework and ensuring that its pharmaceutical sector adheres to international standards. As one of the world’s largest suppliers of generic medicines, India’s credibility in the global pharmaceutical industry depends on maintaining strict quality control and drug safety.
The reassessment also includes fixed-dose combinations (FDCs), where multiple active ingredients are combined into a single drug. In recent years, some of these combinations have been questioned due to concerns over their scientific validity. Earlier this year, an expert committee ruled that certain older FDCs could continue with conditions, while others were ordered to undergo fresh clinical trials. The Government’s firm stance signals that even long-established drugs must now prove their safety and effectiveness under modern scrutiny.
Stricter compliance for companies
As part of broader regulatory reforms, the Government has made pharmacovigilance a mandatory requirement for all pharmaceutical companies. Under the new compliance norms, drug manufacturers must actively monitor adverse reactions and report them to national health authorities. New safety protocols include:
• Regular safety reports: Pharmaceutical firms must submit periodic safety update reports to CDSCO, outlining any new safety data and global regulatory changes.
• Stronger adverse event monitoring: Companies must report all adverse drug reactions to the Pharmacovigilance Programme of India (PvPI) for national database tracking.
• Greater clinical trial transparency: Firms must register trials with the Clinical Trials Registry of India (CTRI) and follow revised Good Clinical Practice (GCP) guidelines to ensure ethical and scientifically sound trials.
• Digital submissions: All regulatory applications and reports must now be filed electronically via the Sugam portal, making the oversight process more transparent and efficient.
The Government has warned that failure to comply with these regulations could result in penalties, including the suspension of drug licences. These steps are expected to bring India’s regulatory practices closer to those of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Strengthening manufacturing
A major component of the regulatory overhaul is the upgrade of Good Manufacturing Practices (GMP), which govern drug production quality. In December 2023, the Government revised Schedule M of the Drugs and Cosmetics Rules, marking the first major update in decades. The new guidelines bring Indian manufacturing standards in line with World Health Organisation (WHO) GMP norms and introduce:
Stronger pharmaceutical quality systems
Comprehensive risk management protocols
Enhanced product validation mechanisms
Stricter equipment and facility requirements
Large pharmaceutical firms were given six months to comply, while smaller manufacturers initially received a one-year extension. However, after industry concerns, the Government extended the deadline to December 2025 for small and medium enterprises (SMEs) that submit a compliance roadmap.
The urgency behind this reform stems from international concerns over Indian drug quality. In recent years, reports of contaminated medicines — most notably toxic cough syrups linked to fatalities abroad — raised alarms about gaps in regulatory enforcement. By mandating higher manufacturing standards, the Government aims to restore global confidence in Indian-made drugs and prevent similar incidents in the future.
Crackdown on unsafe drugs
Regulators are also taking strict action against unapproved and potentially unsafe drugs. This year, the Government banned nimesulide for veterinary use, citing its harmful effects on animal health. Similarly, certain painkiller combinations that were being exported without proper approval have been removed from the market.
Authorities are also phasing out irrational fixed-dose combinations that lack a clear therapeutic benefit. This ensures that only scientifically validated medicines remain available to doctors and patients. The crackdown is part of a broader push to eliminate outdated or ineffective drugs from India’s pharmaceutical supply chain…To be concluded
