Government, NCB mum on taking on FDA babus

MUMBAI; In probably the first such action, a top Food and Drug Administration (FDA) official has written to the state government and the Narcotics Control Bureau recommending that seven of its own officers, including the drug controller of Maharashtra and three joint commissioners, be charged under the stringent Narcotic Drugs and Psychotropic Substances Act for dereliction of duty in the Rs 2,000-crore ephedrine drug haul.The move has created ripples in the organization, dividing the drug regulatory body like never before.
In April this year, the Thane crime branch busted what it claimed was one of the country's biggest drug rackets. It found that the controlled substance ephedrine and its salts were stolen out of the premises of Avon Life Sciences, Solapur, and sold in the illegal drug market after purification. The FDA's vigilance department had subsequently carried out three inspections of the factory and found 28 violations under the NDPS as well as the Drug and Cosmetics Act.
Additionally , the vigilance team under joint commissioner (vigilance) Harish Baijal indicted the FDA officials --right from the drug inspectors to joint commissioners-on various counts. A top FDA official has written to the state government and the Narcotics Control Bureau recommending that seven of its own officers be charged under the stringent NDPS Act for “negligence“ in the Rs 2,000 crore ephedrine drug haul.
FDA joint commissioner (vigilance) Harish Baijal's team found that the officials were negligent of not carrying out timely inspections of Avon premises, granting fresh licences without thorough recordchecking and failing to prosecute the company for breaches. Around 21,500kg of DL ephedrine base was illegally sold to two smaller companies without permission.
Based on the findings, Baijal recommended that seven officials be charged under Section 59 of the NDPS Act, applicable to an officer who stops performing his roles or withdraws from duties. If charged, the FDA officials could face a jail term of up to one year. The report said there was a total failure of regulatory mechanism in narcotics control and blamed officials for facilitating commission of offence by drug dealers.
The report revealed that Avon premises was not inspected even once between 2013 and July 2015 when the Drugs and Cosmetics Act mandates at least one annual visit.The report added the drug inspectors did not send detailed reports of their visits to seniors. The seniors, too, allegedly did not check what was going on in a company manufacturing seven out of eight licensed products with controlled substances. The officials even ignored internal reports of the company that spoke of raw material thefts.
The officers named in the Baijal report are drug controller O S Sadhwani, joint commissioner B R Masal, joint commissioner S T Patil (retired), assistant commissioner S M Sakrikar, assistant commissioner M S Jawanjal Patil, drug inspectors V R Ravi and B D Kadam. The report stated that most violations in the company were committed from 2013, including modifications in the plant that went unnoticed. A stock of 9,500kg of D ephedrine was lying in a tin shed since 2013 and was allegedly being stolen.
Baijal's report, which is with Mantralaya for two months, is awaiting a response from the law and judiciary department on whether FDA officials can be charged under the NDPS Act. In the meantime, a section of the department's officials have alleged that Baijal has wrongly interpreted the department's jurisdiction, which seemingly does not extend to controlled substances.“He has gone on an overzealous drive to implement the NDPS Act, which is the sole lookout of the Narcotics Control Bureau and not FDA 's,“ a senior official told TOI.
The officials have alleged the substance recovered from the Solapur plant is mostly residue and not the real drug. FDA commissioner Harshadeep Kamble told TOIthe officers have been served a showcause notice.“Their responses have started coming in and we will be studying them before taking any disciplinary action. asRegarding the NDPS charges, the government has to decide and convey it to us,“ he said. The Narcotics Control Bureau, too, has kept mum in the matter of prosecuting babus so far.