Hyderabad, India – Indian pharmaceutical companies are facing new manufacturing standards this year as the central government seeks to address concerns over the quality and safety of Indian-made drugs. This move comes after a series of overseas deaths linked to Indian-made drugs since 2022, prompting the government to ramp up scrutiny of pharmaceutical factories in an effort to restore the industry’s reputation.
The new standards, outlined in a notification dated December 28, require manufacturers to take responsibility for the quality of pharmaceutical products and ensure they meet regulatory requirements. Companies must also conduct satisfactory tests on ingredients before marketing finished products and retain samples for further testing or verification. The health ministry has found an “absence of testing of incoming raw materials” during inspections of drug factories, raising concerns about the industry’s adherence to international manufacturing standards.
While the central government has set a deadline for large drugmakers to address these concerns within six months, small manufacturers have requested a 12-month extension, citing heavy debts that could threaten the survival of nearly half of them if required investments are made. The World Health Organization (WHO) and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon, further underscoring the urgent need for improved manufacturing standards.
The pharmaceutical industry in India, which is valued at $50 billion, plays a crucial role in supplying drugs to both domestic and international markets. With concerns over quality and safety, the industry is now under pressure to meet the new manufacturing standards within the specified timeframe. The government’s efforts to address these issues are aimed at ensuring that pharmaceutical products are safe, effective, and meet global manufacturing standards, with potential implications for the industry’s competitiveness and reputation on the international stage.
The new manufacturing standards imposed by the central government highlight the urgency of addressing concerns over the quality and safety of Indian-made drugs. With the industry valued at $50 billion, the government’s push for improved standards is aimed at enhancing the credibility and competitiveness of Indian pharmaceutical companies in the global market. The deadline for large drugmakers to comply with the standards within six months, while small manufacturers have requested a 12-month extension, demonstrates the challenges and financial implications involved in meeting the new requirements. The urgency to address these concerns also reflects the global impact of Indian-made drugs, with links to overseas deaths underscoring the need for stringent manufacturing standards to ensure the safety and effectiveness of pharmaceutical products.