On March 28, 2019, the central government has amended the conditions for supply of sublingual tablets of Buprenorphine + Naloxone FDC and Buprenorphine alone. According to the notification the said formulations shall be supplied to the psychiatric clinics and hospitals in addition to the already designated de-addiction centres set up by the government/ funded by the MoHFW. The notification also requested all State/UT drug controllers to submit detailed list of centres, to which the supply of drug is made, to the office of Drug Controller General (India) periodically indicating the quantity supplied to each centre.

The sublingual tablet of Buprenorphine was first approved by the Central Drug Standard Control Organization in year 1999, followed by FDC of Buprenorphine + Naloxone in year 2008. The said approval comes with the condition that the said formulation shall only be supplied to the designated de-addiction centres set up by the government/ funded by the MoHFW and Ministry of Social Justice and Empowerment and hospital with deaddiction facilities. Subsequently, the association of Psychiatrists through their representation have asked to withdraw the restriction of supply to only the de-addiction centres by listing down various reasons like the formulation demand in the country, the limited numbers of de-addiction centres, and improper definition of deaddiction centre which limits the accessibility of said medicine to the trained psychiatrists in the country.

Thereafter, on August 08, 2018, the 38th Subject Expert Committee of Neurology & Psychiatry1 deliberated and discussed the representation and noted that the existing conditions regarding the restriction on sale and distributions need to be modified and recommended that Buprenorphine sublingual tablets should be allowed to be supplied to psychiatric clinics, hospitals instead of earlier condition that the drug should be supplied to deaddiction centers only. Now therefore, the Central Government after consultation with Ministry of Health And Family Welfare has amended the condition (The insertions are underlined and deletions are struckthrough) as prescribed below:

"The preparation shall be supplied only to the psychiatric clinics and hospitals in addition to the designated de-addiction centre set up by the government of India funded by the Ministry of Health and Ministry of social justice and empowerment and hospital with de-addiction facilities, and a list of centres to whom the supply of drug is made should be made to the office of DCGI periodically indicating the quantity supplied to each centre."

Note – All State/UT drug controllers and manufacturers are directed to comply with the above conditions while granting license to the manufacturers and while suppling of said product respectively.


1. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=NDM=

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