In an effort to end the issues involved in allocating narcotic drugs quota to the pharmaceutical manufacturers in the country, the Centre has appointed Central Bureau of Narcotics (CBN) as the single authority in the country to deal with narcotic drugs quota instead of the present practice of Drugs Controller General of India (DCGI) and the state drugs controllers issuing the quotas to the firms.
The responsibilities for allocation of quotas of narcotic drugs to companies, collecting and compiling the estimates of their requirements for the next year and collecting and compiling consumption details has been transferred to the Narcotics Commissioner, CBN, with immediate effect.
The takeover procedure has already started with the CBN calling for usage details and requirements from the companies online and the pharma firms responding to it, according to a higher official from the Department of Revenue, which is handling the narcotic control mechanism. An official circular regarding the change of administration has been sent to the relevant pharma companies on April 5, 2010.
The move comes in the wake of the recent issues with quota allocation and collecting usage data due to the alleged irresponsible attitude of the central and state drug regulators. The Narcotics Drugs and Psychotropic Substances (NDPS) rules under the NDPS Act, 1985 will also be suitably amended for the change of administration.
“This is part of our efforts to meet the international obligations we have made with the International Narcotics Control Bureau. Under the prevailing system, we have found it difficult to take an account of the requirements for narcotic drugs needed by the pharma industry and we were not getting the details of usage back in time,” said the official on condition of anonymity. The Government of India has to submit the details to the INCB, as per an international agreement.
Until the new amendments to the NDPS rules take place, the narcotics commissioner will have a temporary arrangement to immediately allocate quotas for the year 2010 to companies and also start collecting consumption and other statistics directly from them. “DCGI may not allocate quotas for 2010 to individual states and instead instruct all state drugs controllers to direct companies requiring quotas to the Narcotics Commissioner. DCGI may further submit details of the estimates submitted by different states to the Narcotics commissioner to help in allocating quotas,” says an office memorandum issued by the Department of Revenue.
The government has came across several issues in allocating quotas to the drug companies by the state drug controllers. It has been observed by the department that the state drug controllers have extended the validity of 2009 quota upto March 31, 2010 while the international norms insists on calender year basis for allocation and retrieving of consumption details. The department has to submit the annual statistics to the INCB, Vienna, on calendar year basis and issuance of last year's quota to 2010 would create confusion in assessment of data.
It is also to be recalled that according to reports, the central revenue department has recently come across a serious issue of allocation of codeine phosphate quota, in 2008, by the Food and Drug Administration (FDA), Maharashtra, exceeding almost three times of whatever to be issued according to norms. The CBN has also met the Drug Consultative Committee (DCC), lead by the DCGI, in mid 2009 to alert the lack of interest from the drug regulators to submit the consumption details of narcotic substances allocated to drug companies.