The Maharashtra Food and Drugs Administration (FDA) has cancelled the licences of 10 Ayurvedic drug manufacturers after inspections found serious violations of manufacturing and quality-control rules.
This comes after a statewide inspection drive covering 434 licensed Ayurvedic drug manufacturing units. The companies whose licences were revoked are located in Pune, Baramati, Nashik and other parts of Maharashtra.
The FDA found breaches of the Drugs and Cosmetics Act, 1940, during the inspections. The violations included manufacturing without qualified and authorised technical staff, poor hygiene at production facilities and failures in quality-control systems.
The department also found that some facilities did not have the equipment for manufacturing and testing medicines. In several cases, the quality control department was either not functioning or was not available as required under the regulations.
The inspections also covered manufacturing records and testing procedures. Officials examined batch manufacturing records, raw material records, finished product testing records, standard operating procedures and other documents required for compliant production.
The FDA found that some of the companies did not maintain raw material or batch manufacturing records. In some cases, the information available in these records was inconsistent. Officials also found incorrect manufacturing dates printed on product labels.
Testing of raw materials and finished products was also not being carried out in the affected facilities. Records related to the medical examinations and training of technical staff were missing as well. There was an absence of procedures to prevent cross-contamination between medicines during manufacturing.
Apart from the 10 companies whose licences were permanently cancelled, the inspection campaign identified 135 other Ayurvedic manufacturing facilities as non-compliant. These facilities were issued show-cause notices and asked to explain the violations found during the inspections.
The department also checked if manufacturers were maintaining proper batch records, testing raw materials and finished products, following standard operating procedures and meeting other requirements under the applicable rules.
Recently, Maharashtra Deputy Chief Minister Eknath Shinde had raised concerns over food adulteration. Mundhe presented the issue to Shinde on Tuesday, following which the deputy chief minister called for stronger action against those involved in adulteration.
Shinde said food adulteration directly puts people's lives at risk and should not be treated as an ordinary offence. He pointed to adulterated milk, fake paneer and contaminated food products as serious concerns, particularly because children could be exposed to dangerous illnesses, including cancer.
He described food adulterers as "anti-social elements" and called for tougher legal measures to deter such activities. Shinde said authorities should consider invoking the Maharashtra Control of Organised Crime Act (MCOCA) against food adulterers. He also called for non-bailable offences to be registered.