Manufacturers allowed to supply Buprenorphine Sublingual Tablets to psychiatric clinics: CDSCO

New Delhi: Through a recent public notice, the Central Drugs Standard Control Organisation (CDSCO) has informed about the conditions for the distribution and marketing of Buprenorphine 2mg/0.4mg sublingual tablet and FDC of Buprenorphine+Naloxone (2mg + 0.5mg & 0.4mg + 0.1mg) sublingual tablets.

Buprenorphine sublingual tablets are used as a part of a medical, social and psychological treatment programme for patients addicted to opiate (narcotic) drugs. Treatment is prescribed and monitored by physicians who are specialists in the treatment of drug dependence.

CDSCO had approved Sublingual tablets of Buprenorphine 2mg/0.4mg on 10.03.1999 and FDC of Buprenorphine + Naloxone (2mg + 0.5mg & 0.4mg + 0.1mg) on 02.12.2008 with certain condition, which reads;

"The preparation shall be supplied only to the designated De-addiction centres set up by the Govt. of India funded by the Ministry of Health and Ministry of Social Justice & 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 Drugs Controller General (I) periodically indicating the quantity supplied to each centres”.

In this regard, CDSCO had also written to all the State Drugs Controllers on 24.09.2010 requesting to stipulate the above condition while granting the license to manufacturers for the above drugs.

However, the Association of Psychiatrists through their representation have requested to withdraw the above restriction for supply of sublingual tablet of Buprenorphine and FDC of Buprenorphine and Naloxone sublingual tablet to De-addiction centre only by mentioning various reasons like the need availability in De-addiction centres, improper definition of the country, extremely less De-addiction centres, which is leading to lack of access of said medicines to trained Psychiatrists.

In view of a representation of Association of Psychiatrists, the proposal for deletion of the condition was placed before 38th Subject Expert Committee (Neurology and Psychiatry) in its meeting held on 08.08.2018 for deliberation wherein the Association of Psychiatrists presented their proposal before the committee.

The committee discussed regarding the restriction on sale and proposal and noted that the existing conditions distribution mentioned in letter dated 24.09.2010 needs to be modified and recommended and FDC of Buprenorphine * Naloxone that Buprenorphine 2mg/0.4mg sublingual tablet (2mg+0.5mg & 0.4mg+0.1mg) sublingual tablets should be allowed to be supplied to psychiatric clinics, hospitals instead of the earlier condition that the drug should be supplied to de-addiction centres only.

The recommendation of the Subject Expert Committee was considered by the Directorate in consultation with the Ministry of Health and Family Welfare, Government of India and accordingly the condition laid down earlier is amended as under:-

In place of:

The preparation shall be supplied only to the designated De-addiction centres set up by the Govt. of India funded by the Ministry of Health and Ministry of Social Justice & 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 Drugs Controller General (I) periodically indicating the quantity supplied to each centres".

Read as;

"The preparation shall be supplied to Psychiatric clinics and hospitals in addition to the designated De-addiction centres set up by the Govt. of India funded by the Ministry of Health and Ministry of Social Justice & 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 Drugs Controller General (I) periodically indicating the quantity supplied to each centres".

In view of the above, CDSCO has directed to stipulate the above condition while granting a licence to the manufacturers of the said products and to direct the existing manufacturers of the said products to comply with the above conditions.

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