Substandard Drugs from MSME Pharma Sector Pose Public Health Risks

India's micro, small, and medium enterprise (MSME) pharmaceutical sector is under scrutiny following revelations that a significant proportion of these companies are producing substandard drugs. Data from the Central Drugs Standard Control Organisation (CDSCO) indicates that over 65% of MSME firms have been found manufacturing drugs that do not meet quality standards. This alarming trend has prompted nationwide inspections and raised concerns about the safety of medicines supplied to the public.

The CDSCO, in collaboration with state drug inspectors, has been conducting risk-based inspections since December 2023. These inspections involve collecting drug samples from various distribution points and testing them in government-approved laboratories. In April alone, approximately 60 drug samples failed quality tests and were categorized as Not of Standard Quality (NSQ). Among the companies flagged were Gidsha Pharmaceuticals in Gujarat, Martin and Brown Biosciences in Solan, Himachal Pradesh, and Sai Parenterals in Hyderabad. The drugs in question included carboxymethylcellulose sodium eye drops, bupivacaine hydrochloride injections, and calcium carbonate and vitamin D3 tablets. 

The implications of substandard drugs are far-reaching. They can lead to treatment failures, prolonged illnesses, and in severe cases, fatalities. The lack of effective regulatory oversight and enforcement mechanisms exacerbates the problem. Currently, the guidelines for drug recalls are not legally binding, placing the responsibility on manufacturers to withdraw faulty products voluntarily. This voluntary approach has proven ineffective, as evidenced by the persistence of substandard drugs in the market. 

In response to these challenges, the government has initiated measures to strengthen the regulatory framework. Revised norms under Schedule M of the Drugs and Cosmetics Rules mandate that all pharmaceutical manufacturers, including MSMEs, comply with Good Manufacturing Practices (GMP). Companies with annual turnovers above ₹250 crore are required to adhere to these standards within six months, while smaller firms have a one-year deadline. However, the implementation of these norms has been met with resistance from industry associations, citing concerns over competitiveness and the potential impact on the availability of medicines. 

The situation calls for urgent reforms in India's pharmaceutical regulatory system. There is a need for stricter enforcement of quality standards, mandatory drug recalls, and greater transparency in the inspection and approval processes. Ensuring the production of safe and effective medicines is paramount to safeguarding public health and maintaining trust in the pharmaceutical industry.

Source: Outlook Business