FDA cancels licences of 10 Ayurvedic drug-manufacturing companies

The companies were found defaulting during the FDA’s comprehensive inspection drive of 434 licenced Ayurvedic drug-manufacturing establishments across the state

MUMBAI: The state Food and Drugs Administration (FDA) has permanently cancelled the licences of ten companies manufacturing ayurvedic products after serious violations of the Drugs and Cosmetics Act, 1940, were found in their operations. The companies, based in Pune, Baramati, Nashik and other places, were found defaulting during the FDA’s comprehensive inspection drive of 434 licenced Ayurvedic drug-manufacturing establishments across the state.

FDA cancels licences of 10 Ayurvedic drug-manufacturing companies

During the inspections, various aspects were scrutinised, including the adequacy of the factory premises, availability of the requisite technical manpower, implementation of good manufacturing practices, functioning of the quality control department, batch manufacturing records, testing records of raw materials and finished products, standard operating procedures and so on. Show-cause notices were issued to 135 Ayurvedic manufacturing establishments that were found to be non-compliant, which have been asked to submit explanations regarding the observations recorded during the inspections.

The FDA press note said that manufacturing in the ten firms whose licence was cancelled was being carried out in the absence of qualified and approved technical personnel. The quality control department was not functioning, the necessary machinery and equipment required for manufacturing and testing were not available and the manufacturing premises were unhygienic and did not comply with prescribed standards.

Apart from this, there was an absence of batch manufacturing records and raw material records, as well as discrepancies in such records and incorrect manufacturing dates on product labels. Testing of raw materials and finished products was not being carried out and records of raw materials were not available.

Records relating to the medical examination of technical staff/workers were also not available and neither were records of training of technical staff. There were no procedures in place to prevent cross-contamination of medicines.

FDA commissioner Tukaram Mundhe said, “Ayurvedic medicines are widely used by the public. The manufacture of classical medicines must be carried out as prescribed in recognised authoritative reference texts, while the manufacture and quality control of patent and proprietary medicines must be undertaken in accordance with the prescribed standards under the applicable rules. Strict action will be taken against Ayurvedic manufacturers who fail to comply with these requirements.”

MCOCA for milk adulterers, says Shinde

MUMBAI: On Tuesday, Mundhe gave a presentation to Eknath Shinde, after which the deputy CM expressed his anger. “Food adulteration is not an ordinary offence but amounts to directly playing with the lives of citizens,” he said. “Young children consume large quantities of milk, and counterfeit paneer, and adulterated food products can expose them to serious diseases such as cancer. Adulterers are directly putting the lives of these children at risk.”

Calling such adulterers “anti-social elements”, Shinde said that strict action needed to be taken against them under the Maharashtra Control of Organised Crime Act to set a strong deterrent. “Non-bailable offences should be registered so that they cannot exploit legal loopholes,” he said. He also directed that a special legal team be formed immediately and steps be taken to strengthen the legal process in these cases such as seeking the assistance of renowned and senior legal experts.