Govt Eases Restrictions On Buprenorphine Sales

New Delhi, 3 April 2019: The health ministry has eased the conditions for distribution and marketing of buprenorphine sublingual tablets and buprenorphine-naloxone fixed dose combination, a medication for the treatment of opioid addiction, to make them available to all psychiatric clinics and hospitals in the country.

So far, the manufacturers were allowed to supply the formulation only to designated de- addiction centres. Buprenorphine belongs to a class of medicines called mixed opioid agonist- antagonists. It helps prevent withdrawal symptoms caused by stopping other opioids. Cleared by the Drugs Controller General of India (DCGI) way back in 1999, it has been prescribed by clinicians as part of a complete treatment programme for drug abuse such as compliance monitoring, counselling, behavioral contract and lifestyle changes.

The decision has been taken following representations from various psychiatrists' associations. The clinicians have complained about the unavailability of the crucial drug, citing low number of registered de-addiction centres.

According to the new circular issued by the DCGI to state licensing authorities, the proposal from the psychiatrists to ease the condition was approved by the subject expert committee for neurology and psychiatry last year. The ministry has now cleared the proposal and amended the regulations. “The preparation shall be supplied to psychiatric clinics and hospitals in addition to the designated de-addiction centres set up by the government of India funded by the Ministry of Health and Ministry of Social Justice and Empowerment and hospitals with de-addiction facilities and a list of the centres to whom supply of the drug is made should be made to the office of DGCI periodically indicating the quantity supplied to each centres," the circular reads. 

The move comes amid growing concerns over rising cases of drug dependence and a government plan to implement a policy to address the menace. The National Drug Demand Reduction Policy draft was withdrawn recently to consider data from a survey being conducted by the National Drug Dependence Treatment Centre under the AIIMS to reach an estimated figure of drug users.

The draft policy moots regulation of over-the-counter sale of sedatives and pain killers. It also proposes upgrading existing de-addiction centres in selected pilot districts. New such centres would be set up in 25 factories and major industrial establishments, 25 prisons and 25 juvenile homes. As many as 25 separate de-addiction centres for women in prisons are also planned. Pharmabiz