Drug Manufacturing units are under the radar of the Central Drugs Standard Control Organization (CDSCO) for not following protocols.
Drug inspection notification from the ministry
On 27th December, Tuesday, the Central Drugs Standard Control Organization (CDSCO) under the direction of the Union Minister of Health and Family Welfare and Chemical and Fertilizers, Dr. Mansukh Mandaviya started conducting joint inspections of identified drug manufacturing units along with the state drugs control administration as per the risk-based approach.
It is a joint inspection that is being conducted all over the country according to standard operating procedures. It was notified that a committee of two joint drug controllers has been constituted at CDSCO (HQ) to monitor the process of inspection. reporting and subsequent action so as to ensure compliance with the drugs and cosmetics act of 1940 and the rules thereunder. This is to ensure high standards of quality compliance with respect to drugs manufactured in the country.
Maiden Pharmaceuticals Case
It is believed that the ministry took steps due to the recent mishap where cough syrups made by New Delhi-based Maiden Pharmaceutical, led to the death of at least 66 children in the African Nation of Gambia, spoiling India’s image as a Pharmacy of the world. Another Maiden factory in Haryana was recently inspected where again gaps were found in the good manufacturing practices, norms of which are specifically laid down by the World Health Organisation (WHO).
It was only after the suggestion by the experts who were assigned to investigate the Maiden case, that the official step to randomly inspect the drug factories to check for standards was taken.
WHO in a briefing on October 5, 2022, issued a medical product alert for cough syrup Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makeoff Baby Cough Syrup, and Magrip N Cold Syrup- manufactured and exported by Maiden.
It should be highlighted that the test reports did not find any contamination in the samples of cough syrup lifted for inspection by Indian regulatory authorities but the government admitted that the company did compromise on WHO good manufacturing practices compliance, based on which it was asked to stop production by the state drug regulator.
Schedule M and Schedule U of the drug rules clearly mention the GMP requirements were not being adhered to and were contravened by the firm during the manufacturing and testing of the drugs. The firm also did not maintain and produce complete records of manufacturing and testing as per the rules. Several documents were examined by investigating team which clearly indicated that the firm is not meeting the requirements of drug rules,1945 under the drugs and cosmetics act,1940 across its manufacturing and testing units.
This was viewed as a serious breach of protocols during the investigation and exposed potential risk to the quality safety and efficacy of the drugs introduced. Therefore all the manufacturing activity in the firm was stopped immediately under Section 22(1d) of the drugs and cosmetics act 1940, and the rules framed thereunder till further order, in the public interest, without prejudice to further action and the matter.
Safer Drug Manufacturing Practices
The official notification said that the objective of drug regulation is to make sure the safety and efficacy and quality of the drugs available in the country are not compromised. The drug control administration is required to ensure all the manufacturing units comply with the drugs and cosmetics act of 1940 and the rules thereunder, especially the requirements of good manufacturing practices (GMP).
The ministry said that the action plan for nationwide inspection of manufacturing units that are identified to be at risk of manufacturing and not of standard quality ( NSQ)/ adulterated/ spurious drugs was made prior to carrying out of the inspection.