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A report by the vigilance department of the Maharashtra Food and Drug Administration (FDA) has called for a departmental inquiry against seven of its own officers from Solapur, Pune and Mumbai under Section 59 of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, owing to alleged discrepancies at Avon Life Sciences Ltd — earlier called Avon Organics Ltd — where 18.5 tonnes of banned Ephedrine drug, valued at Rs 2,000 crore, was seized in April this year. The Thane police have so far arrested 12 persons, including wholetime director Manoj Jain who later resigned, in the case. Names of drug lord Vicky Goswami and former Bollywood actor Mamta Kulkarni have also emerged in the case.
The FDA’s three-member team under joint commissioner of Vigilance Harish Baijal, which visited the chemical manufacturing unit in Solapur thrice between April 18 and May 30 this year, found that it had been involved in major violations since 2013, to which inspecting authorities had turned a blind eye. The final report has been submitted to the police commissioner of Thane, superintendent of Solapur police, and zonal director of the Narcotics Control Bureau (NCB), drawing names of seven FDA officials — SM Sakrikar (assistant commissioner), V R Ravi (drug inspector), M S Jawanjal Patil (assistant commissioner) and Bhagyashree Kadam (drug inspector) from Solapur, B R Masal (former joint commissioner, Pune, and now Mumbai’s joint commissioner) ST Patil (former joint commissioner, Pune) and O S Sadhwani (drug controller of Maharashtra).
# Avon Life Sciences was given product approval for eight drugs. Of them, there were no records of the manufacture of two drugs, Ephedrine sulphate and pseudoephedrine sulphate, in 2011 and 2012. The drug inspectors issued renewal licences without inspection of these two controlled substances, against Rule 68-A. n In September 2009, Avon sent a huge stock of DL Ephedrine to another firm for “jobwork”. According to the report, “this transaction should have been a matter of concern” as it never came back and is suspected to have been used to manufacture Ephedrine.
# The vigilance team found that Avon maintained no record of the procedure used to destroy controlled substances, the destruction data, or documents on standard operating procedures. This was also missed by drug inspectors during their routine inspection. n The Solapur FDA office was negligent in yearly inspections at the unit. While a detailed report had to be sent for each inspected unit to the controlling authority, there were serious lapses on part of the inspectors. A huge stock of 9,500 kg of D Ephedrine Hydrochloride had been stored in a temporary tin shed since 2013, which went unnoticed.
# A controlled product, Ephedrine Hemihydrate, was sent for “jobwork” in 2006 and never recovered. No information was given on that by the FDA Solapur or Avon. Similarly, another stock of 4.7 kg of Pseudoephedrine Hydochloride was found missing. In another instance, stock of 8,500 kg and 13,000 kg of DL Ephedrine base was sold illegally to other firms. These substances were either by-products or waste, which had to be ideally destroyed. They are, however, believed to have been sold illegally to make Ephedrine.
# Avon was certified for “Good Manufacturing Practices” for its products as per WHO guidelines. The report said despite objectionable work procedures found during inspection, the certifying authority went ahead and issued the certificate to the company. n An inspection by a consumer safety officer from the US FDA in February this year found “three objectionable practices” in the company. The FDA Solapur office has no records of the inspection by the US FDA.
# The FDA probe also found that controlled substances had been stolen several times allegedly by Avon employees, but this was never conveyed by the company head to the zonal officer of the NCB. NCB officers too have found negligent in not conducting a proper inquiry into the missing controlled substances.
According to FDA Commissioner Harshdeep Kamble, the report has been presented to the law and judiciary department for further probe. “We are waiting for their report now,” he told The Indian Express. Advocate Ayaz Khan, representing Manoj Jain, refuted the FDA’s claims. “Sale of DL Ephedrine is not necessary to be notified under the Controlled Substances Act, 1993, as it is not a controlled substance but an isomer of Ephedrine. I don’t know on what basis the FDA has made its observations,” Khan said.