Quality of generic medicines 

The Pharmaceutical Quality System mandates manufacturers to assume responsibility for the quality of pharmaceutical products to ensure that they are fit for their intended use and do not pose any risk to patients due to inadequate safety, quality, or efficacy. The National Medical Commission’s (NMC’s) new regulations, which make prescriptions of generic medicines mandatory for registered medical practitioners, put the quality of generic medicines in the spotlight. Official data reveals that of the total 96,713 generic drug samples tested in 2022–23, 3,053 were declared not of standard quality, and 424 were declared spurious or adulterated. A closer look at the data shows that the number of samples declared spurious or adulterated and of substandard quality has increased over the past few years. The data is reflective of the apprehension raised by the Indian Medical Association over the quality of generic drugs when they objected to the NMC regulation on writing prescriptions for medicines. Nevertheless, the prescription of low-cost generic medicine is critical to shielding a large section of patients from increasing out-of-pocket expenditures on purchasing branded medicines prescribed by their doctors. This can be possible only when quality control of generic medicine gets the most attention from the government. The government amended the Drugs and Cosmetics Act, 1940, under the Drugs and Cosmetics (Amendment) Act, 2008, to provide stringent penalties for the manufacture of spurious and adulterated drugs and make certain offences cognizable and non-bailable. The pertinent question that needs to be asked is whether the strength of drug inspection machinery matches the rising number of wholesale and retail medical outlets for rigorous inspections to detect substandard, spurious, or adulterated drugs manufactured or imported in the country. The shortage of drug inspectors in the country has been a chronic problem, despite the issue being raised at different forums for many decades. The Parliamentary Standing Committee on Health and Family Welfare, in its report on the Drug and Cosmetics Bill, 2007, highlighted that, keeping in view the wide-ranging national concern about the quality and efficacy of drugs and pharmaceuticals and an urgent need for a world-class drug regulatory system in the country, the Ministry of Health and Family Welfare constituted an Expert Committee under the Chairmanship of Dr. R.A. Mashelker, Director-General, CSIR, in 2003 to suggest further measures to improve the control and management of drug administration in the country. The report of the parliamentary panel also dealt with the issue of a shortage of drug inspectors. The Expert Committee, in its 2003 report on “A Comprehensive Examination of Drug Regulatory Issues, including the Problem of Spurious Drugs,” concluded that the problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the state and central levels, inadequate testing facilities, a shortage of drug inspectors, non-uniformity of enforcement, a lack of specially trained cadres for specific regulatory areas, the non-existence of a data bank, and the non-availability of accurate information. The Committee also noted that the onus of monitoring drug manufacturing standards, drawing and testing samples, and taking legal action against infringers rested primarily with state drug regulatory agencies. Hence, for any effective intervention, it was essential that the state governments strengthen and support their drug control organizations. This will include the provision of additional personnel with top-class technical and investigative skills, appropriate infrastructure, and adequate resources. Despite several directions from the central government, many state governments were yet to upgrade their drug testing facilities, and the competence of their regulatory infrastructure was not at the desired level, the report adds. In December 2023, the government informed parliament that the Central Drugs Standard Control Organisation was functioning with drug inspectors with less than half the sanctioned strength. This speaks volumes about the issue of the gap in the drug regulatory and enforcement system being in the domain of policymakers and stakeholders for a considerably long period, and it is baffling that generic drug production continues to grapple with problems of standard and quality of medicines as well as shortages of drug inspectors. Ironically, updated information on the current strength of drug inspectors and drug regulatory authorities in various states is not available in the public domain, making it difficult for stakeholders and policymakers to arrive at conclusions regarding the quality of generic as well as some non-generic medicines being sold to patients. NMC’s regulations on generic medicine can be effective only when central and state drug regulatory authorities are well equipped to ensure the quality of drugs being manufactured, imported, and sold. Patients being given the option to choose between generic and branded drugs is of paramount importance to reducing their cost burden. At the same time, the quality of both types of drugs that conform to regulatory and prescribed standards is a prime public health concern that cannot be compromised. The government’s initiative to push generic drugs is praiseworthy, but stronger drug inspection machinery is a must to make it successful.