Ephedrine seizure: dept seeks CM nod to probe 12 FDA officials

“As per procedure, an independent departmental inquiry will begin against the officers,” said Sanjay Deshmukh, Secretary, Medical Education and Drugs department. (Representational Image)

The Maharashtra Medical Education and Drugs department has sought the chief minister’s approval to initiate a departmental inquiry against 12 Food and Drug Administration (FDA) officials in a 2016 case of seizure of ephedrine from pharma company, Avon Life Sciences Ltd, from its Solapur manufacturing unit.

Ephedrine, the sale of which is banned in India, is used for treatment of asthma and bronchitis. It is, however, used illegally to make party drug crystal meth, a psychotropic substance monitored under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985.

The departmental inquiry comes after FDA’s internal inquiry report had recommended action against seven of its own officers under Section 59 of the NDPS Act. In April 2016, Thane police had raided and seized allegedly 18.5 tonnes of ephedrine, then valued at Rs 2,000 crore, from the Solapur manufacturing unit. Following the seizure, FDA’s internal inquiry found 28 discrepancies at Avon Life Sciences Ltd, earlier Avon Organics Ltd, and held several FDA officers accountable for violations.

In the wake of the inquiry report, the Medical Education and Drugs department sought opinion from the Narcotics Control Bureau (southwest region) and the Law and Judiciary department. The Law and Judiciary department said that while the seven officers must not be held responsible under the NDPS Act, as proposed by FDA’s inquiry report, other charges of negligence in monitoring Avon’s Solapur unit may be probed. The last inspection by a drug inspector before the Thane police raid was conducted in 2015.

“As per procedure, an independent departmental inquiry will begin against the officers,” said Sanjay Deshmukh, Secretary, Medical Education and Drugs department.

The inquiry will be held under the Maharashtra Civil Services (conduct and appeal) Rules. The internal inquiry report of FDA, by a three-member committee, stated that the Solapur unit was involved in major violations since 2013. Robbery of controlled substance was found several times by company employees but it was never conveyed by Avon to the zonal officer of NCB, the report stated.

The pharmaceutical company was given product approval for eight drugs. Of them, there were no records of ephedrine sulphate and pseudoephedrine sulphate’s manufacture in 2011 and 2012. Another controlled product, ephedrine hemihydrate, was sent for job work in 2006 and never recovered. No records have been submitted by the unit on that.

Other violations, as per the inquiry report, found that a stock of 4.7 kg of pseudoephedrine hydochloride was found missing. This substance, believed to be sold illegally, can be refined to make ephedrine. Another stock of 8,500 kg and 13,000 kg of DL ephedrine base was sold illegally to Malladi Drugs and Emboi Ltd. Even this batch could be refined to make ephedrine.

The report stated that seven FDA officers, then posted in Solapur, Pune and Mumbai, including S M Sakrikar (assistant commissioner), V R Ravi (drug inspector), M S Jawanjal Patil (assistant commissioner), Bhagyashree Kadam (drug inspector) from Solapur, B R Masal (joint commissioner, Pune), S T Patil (joint commissioner, Pune) and O S Sadhwani (drug controller of Maharashtra) were negligent in monitoring.

Sources from the department said four more names were later added. “In total, inspections have revealed 12 FDA officers have to be probed in this case,” an official said.