Based on official statistics, the Central Drugs Standard Control Organisation (CDSCO) revealed in December 2023 that approximately 7.7 percent of the drug samples it assessed were classified as being of inferior quality (NSQ). Nevertheless, no samples were identified as counterfeit or incorrectly labeled.
As per the monthly drug alert from CDSCO, about 78 out of the 1008 drug samples tested in December 2023 were identified as not meeting the standard quality (NSQ), while the remaining 930 samples were confirmed to be of standard quality.
Some of the products that failed the quality test include Pan-40 (pantoprazole gastro-resistant tablets) produced by Alkem Health Sciences, Mafnac-SPAS (mefenamic acid and paracetamol) tablets manufactured by Laborate Pharmaceuticals, Zensartan-AM tablets (telmisartan and amlodipine) made by Windlas Biotech, sodium valproate 200 mg tablets and Moxizee-P (moxifloxacin and prednisolone acetate eye drops) by Zee Laboratories. Additionally, there were multiple samples of Heparin sodium injection 5000 IU/5ml from Alliance Biotech, Streptomycin (streptomycin injection 0.75mg), and Oxytetracycline injection from Par Pharmaceuticals, among other products, that did not pass the quality test.
Furthermore, the samples contain two tablets containing calcium and vitamin D3, which are unmarked and do not have any details regarding their batch number, production, or expiry dates. These tablets are identified as being produced by Kanha Biogenetic in Baddi.
The CDSCO declared in November 2023 that 5.2% of the drug samples it examined were classified as Not of Standard Quality (NSQ). Furthermore, there was one sample found to be counterfeit and another labeled incorrectly.
The test results for November were recently published by the drug regulatory agency. These results showed that 62 out of the 1,197 samples that were tested did not meet the necessary standards. The remaining 1,133 samples were determined to meet the required quality standards.
In the fiscal year 2022-23, the ministry of health and family welfare conducted tests on 89,729 drug samples. Out of these samples, 422 were identified as counterfeit or containing impurities. Additionally, 2,921 samples were found to be of substandard quality. Moreover, 642 cases were filed in court against individuals involved in the production, sale, and distribution of fake or adulterated drugs, resulting in the arrest of 262 people.
During the 2021-22 financial year, a grand total of 88,844 examinations were conducted. Among these examinations, 2,545 samples were determined to be not of standard quality (NSQ), while 379 samples were discovered to be fake or contaminated. Moreover, 592 legal actions were commenced as a result. Furthermore, a total of 450 individuals who were implicated in the manufacturing, selling, or distribution of counterfeit or contaminated medications were apprehended.
The Ministry has stated that there are various factors that can cause drugs produced by manufacturers to not meet quality standards. These factors can vary from not following the manufacturing license requirements, such as Good Manufacturing Practices and Good Laboratory Practices. To address concerns about the quality of medicines made and distributed from India, both within the country and globally, the CDSCO has collaborated with state drug regulators to carry out inspections based on identified risks across the nation.
On December, in the Rajya Sabha, Dr. Bharati Pravin Pawar, a minister of state in the health and family welfare ministry, announced that the Central Drugs Standard Control Organization (CDSCO) and State Drugs Controllers (SDCs) have examined 261 drug manufacturing facilities to assess their adherence to regulations. These inspections were performed using a risk assessment methodology.
The selection of companies was based on various risk factors, including the number of drugs classified as Not of Standard Quality, customer grievances, and the significance of the products.
According to the Minister, the State Licensing Authorities have carried out more than 200 actions in line with the regulations stated in the Drugs Rules of 1945. These actions include sending show cause notices, directing the halt of production, as well as suspending or revoking licenses or product licenses. These actions were taken based on the findings from inspections.
Laghu Udyog Bharati (LUB), a national organization that advocates for micro and small industries, has indicated in previous reports that assessing whether a drug is not of standard quality (NSQ) requires the careful examination of multiple factors. These potential damage during transportation, quality evaluations, the accuracy of laboratory analysis, storage conditions, and other pertinent considerations.
They stressed the importance of addressing these issues in a comprehensive manner, rather than solely concentrating on the pharmaceutical formulations industry, in a letter to Dr. Mansukh Mandaviya, the Minister of Health and Family Welfare. They proposed that the CDSCO Drug Alerts should furnish detailed data on the NSQ samples and the overall quantity of high-quality medications, with the aim of improving their quality and maintaining confidence in Indian medicines.
Dr Rajesh Gupta, the Head of the Pharmaceutical Committee of Laghu Udyog Bharti in India and the State president of the Himachal Drug Manufacturers Associations in Baddi, has recently appealed to the drug regulator. He urged them to carefully investigate the various factors that contribute to the ineffectiveness of a drug during the sample testing carried out by pharmaceutical companies. This should be done before making a final decision on whether to categorize those samples as Not of Standard Quality (NSQ) samples.
The industry association has asked the drug regulatory body to allow to cross-check the information of drugs that have passed the quality test, along with other pertinent details, before making the list public. The regulatory body should also think about sharing this information to improve the process of alerting about drugs.