(a) the criteria for allotting quota of morphine and narcotic drugs to the pharmaceutical companies;
(b) the details of pharmaceutical companies allotted the said quota during the last three years,
State-wise; and
(c) the rules regarding utilisation of said quota by the pharmaceutical companies and punitive
measures prescribed for the violation of these rules?
MINISTER OF THE STATE IN THE MINISTRY OF HEALTH & FAMILY WELFARE (SHRI GHULAM NABI AZAD)
(a) to (c) The Department of Revenue, Ministry of Finance which is the nodal Ministry relating to
administration of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985 has entrusted
the responsibility of allocation of quota of morphine or narcotic drugs from April 2010 onwards
to the Narcotics Commissioner, Central Bureau of Narcotics, Gwalior (Madhya Pradesh). Before
that, the Drugs Controller General (India) [DCG(I)] allocated the quota of narcotic drugs to
the State Drug Controllers. The allotment of quota to pharmaceutical companies is the sole
responsibility of the State Drug Controllers.
The quota of narcotics drugs is allotted to a pharmaceutical company having a valid manufacturing license
indicating its product list (containing narcotic drugs as an ingredient of the product to be manufactured)
for manufacture or distribution of drugs, issued by the State Drug Controller under the provisions of the
Drugs and Cosmetics (D&C) Rules, 1945 and a license to possess the narcotic drugs issued by the State Excise
Commissioner under the provisions of the State NDPS Rules. While deciding the quantum of quota, the following
factors are generally taken into account:
(i) The estimate for consumption of a particular narcotic drug as approved by the International
Narcotic Control Board (INCB), Vienna, Austria.
(ii) The quota assigned to the company in the previous year;
(iii) The quantity of narcotic drug consumed by the company in the previous year.
The utilization of quota by the individual company is reported to the State Drug Controller in Form C
of the NDPS Act, 1985. The State Drug Controller submits a compiled report of its State, to the DCG(I)
(now the Narcotics Commissioner) for further compilation on all India basis for onward transmission to
the INCB. Punitive measures as prescribed under the D&C Act, 1940, the NDPS Act, 1985 and the State NDPS
Rules are taken by the State Drug Controllers for violation the provisions of these Acts / Rules.