CDSCO declares around 7.7% of drug samples tested in December as NSQ drugs

According to official data, in December 2023, the Central Drugs Standard Control Organisation (CDSCO) reported that nearly 7.7 percent of the drug samples it examined were determined to be of substandard quality (NSQ). However, there were no samples found to be spurious or misbranded.

According to the CDSCO’s monthly drug alert, out of the 1008 drug samples that were tested in December 2023, approximately 78 were found to be not of standard quality (NSQ), while the remaining 930 samples were determined to be of standard quality.

Among the products that did not pass the quality test are Pan-40 (pantoprazole gastro-resistant tablets) manufactured by Alkem Health Sciences, Mafnac-SPAS (mefenamic acid and paracetamol) tablets produced 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) manufactured by Zee Laboratories, as well as 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.

Additionally, the samples consist of two calcium and vitamin D3 tablets that are not labeled, lacking any information regarding their batch number, manufacturing, or expiration dates. These tablets are identified as being manufactured by Kanha Biogenetic in Baddi.

In November 2023, the CDSCO announced that 5.2% of the drug samples it tested were determined to be of Not of Standard Quality (NSQ). In addition, one sample was identified as spurious and another as misbranded.

The drug regulator recently released the test results for November, revealing that out of the 1,197 samples tested, 62 were found to be not meeting the required standards (NSQs). The remaining 1,133 samples were deemed to be of standard quality.

According to the ministry of health and family welfare, in the fiscal year 2022-23, a total of 89,729 drug samples underwent testing. Among these, 422 drug samples were determined to be counterfeit or mixed with impurities. Furthermore, 2,921 drug samples were found to be not of standard quality (NSQ). Additionally, there were 642 cases brought to court for the production, sale, and distribution of counterfeit or adulterated drugs, leading to the arrest of 262 individuals involved in these activities.

In the fiscal year 2021-22, a total of 88,844 tests were carried out. Out of these tests, 2,545 samples were identified as NSQ, 379 samples were found to be spurious or adulterated, and 592 prosecutions were initiated. Additionally, 450 individuals involved in the production, sale, and distribution of counterfeit or adulterated drugs were arrested.

According to the Ministry, there are multiple reasons why drugs manufactured by manufacturers may not meet quality standards. These reasons can range from not adhering strictly to the requirements of the manufacturing license, such as Good Manufacturing Practices and Good Laboratory Practices. In response to reports of quality issues with medicines produced and distributed from India, both domestically and internationally, the CDSCO has partnered with state drug regulators to conduct risk-based inspections nationwide.

Dr. Bharati Pravin Pawar, minister of state in the ministry of health and family welfare, stated in Rajya Sabha on December the Central Drugs Standard Control Organization (CDSCO) and State Drugs Controllers (SDCs) have carried out inspections of 261 drug manufacturing premises in order to evaluate their compliance with regulations. The inspections were conducted based on a risk assessment approach.

The companies have been selected according to risk factors such as the quantity of drugs labeled as Not of Standard Quality, customer complaints, and the importance of the products.

The Minister stated that the State Licensing Authorities have taken over 200 actions, such as issuing show cause notices, ordering the cessation of production, and suspending or canceling licenses or product licenses, in accordance with the regulations outlined in the Drugs Rules of 1945, based on the results of inspections.

According to previous reports, Laghu Udyog Bharati (LUB), the nationwide group that represents micro and small industries, stated that determining whether a drug is not of standard quality (NSQ) involves considering various factors such as damage during transportation, quality evaluations, effectiveness of laboratory analysis, storage conditions, and other relevant aspects in a comprehensive manner.

In a letter to Dr Mansukh Mandaviya, the Minister of Health and Family Welfare, they emphasized the need to tackle these problems comprehensively, not just focusing on the pharmaceutical formulations sector. They suggested that the CDSCO Drug Alerts should provide complete information on the NSQ samples and the total number of high-quality medicines to enhance their quality and uphold trust in Indian medicines.

Dr Rajesh Gupta, who is the All India Head of the Laghu Udyog Bharti Pharmaceutical Committee and also the State president of the Himachal Drug Manufacturers Associations in Baddi, recently made a plea to the drug regulator. He requested that they thoroughly examine the different elements that contribute to the lack of effectiveness of a drug during the sample testing conducted by pharmaceutical companies, before making a final determination on the inclusion of those samples in the list of Not of Standard Quality (NSQ) samples.

The association has requested the drug regulator to give the industry a fair opportunity to verify the details of drugs that have successfully passed the quality test, along with other relevant information, before releasing the list. The regulator should also consider publishing these details to enhance the drug alert process.

When examining the matter of NSQs in India, it is important to consider the country’s diverse geography and climate. The quality and stability of the product are greatly influenced by the specific climatic conditions of the storage and transportation locations, which present numerous difficulties.