Cases of substandard drugs sully image of pharma industry
Emergence of several cases of substandard drugs from the pharmaceutical companies of Himachal every month has become a cause of concern for the common man. Besides besmirching the image of the industry, which claims to provide every third drug in the domestic market, it has exposed the shoddy regulation in the state. Several firms habitually err on producing quality drugs with multiple samples failing quality parameters every month. Himachal has 650 pharmaceutical units operating in various industrial clusters.
“Substandard medicines are meant the treatment of chronic and infectious diseases, causing disease progression, drug resistance and in extreme cases cause death,” point out health experts.
According to a Health Ministry survey, the national percentage of substandard medicines stands at 3.16 per cent while this figure was significantly lower at 1.22 per cent for the last three years in Himachal which accounts for 33 per cent of drugs sold nationally.
The State Drugs Control Administration (DCA) claims it conducted 142 inspections from January 2023 to October 2024 jointly with the Central regulatory authorities and action was taken against 116 pharmaceutical companies. Apart from temporary suspension of manufacturing of particular products and initiating legal proceedings, the erring companies are directed to review and rectify their manufacturing processes.
Limited success has been, however, been attained in checking habitual offenders despite the department devising standard operating procedures (SOPs) to deal with such erring firms. One finds the erring companies figuring in the list of substandard drugs time and again with some finding a mention for years in such lists. Companies whose samples are repeatedly found spurious or grossly substandard are supposed to be inspected on a monthly basis while other repeat offenders are supposed to be inspected on a quarterly basis.
In a bid to ensure compliance of norms and ascertain that patients are not at risk due to inadequate safety, quality or efficacy issues of the medicines, the Union Government has made it mandatory for all pharma firms to upgrade their facilities as per Schedule M of the Drugs and Cosmetics Rules, 1945. This will bring them at par with the global standards including the World Health Organisation norms.
These rules have been devised to overcome the lacunas in the manufacturing by adopting upgraded standards. As per the revised norms, the manufacturing area has to be divided into eight areas or rooms for key products like injectibles where specific area for each section has also been prescribed. In September, as many as 11 injections were declared not of standard quality among 25 drug samples which failed quality parameters. This is an alarming number as vaccines help control infectious disease.
It was observed that despite space constrain some firms were manufacturing several products like injections, tablets, liquids, etc., and this often led to quality issues.
The incorporation of revised Schedule M is slated to introduce strict quality parameters in the manufacturing standards. The companies will be required to incorporate major changes such as introducing pharmaceutical quality system, ensuring quality risk management, reviewing quality of the product, validating the equipment, self-inspecting, along with approving suppliers audit and validating a Good Manufacturing Practices -related computerised system.
Issues such as inappropriate documentation, which include improper record of testing of drug batches, lack of maintenance of machinery, non-functional air handling units and dysfunctional lab equipment, lack of self-assessment, absence of internal product quality review, faulty designs of manufacturing and testing, etc., have been raised by the drug regulators in the risk-based assessments. These issues will be adequately addressed once the companies adopt the revised standards. It will be a major step towards ensuring quality drug manufacturing.
While larger companies with a turnover of Rs 250 crore were require to comply by July 1, those under the micro small and medium enterprises category are supposed to ensure compliance by December 28. Those failing to comply will face suspension of their licence or a penalty.
