The product licenses for drugs falling under the definition of narcotic drugs and psychotropic substances will henceforth be issued by the Central Licensing Approval Authority (CLAA), a joint body consisting of DCGI and the state drug controllers. Unhappy with the existing system of SLAs issuing the licenses, the DCGI has taken initiative to shift the authority in this regard.

The government has already issued draft rules Drugs and Cosmetics (4th Amendment to Rules 2009) in mid June to bring in the narcotic drugs and psychotropic substances to the purview of CLAA. At present, the product license for these drugs is issued by the state drug controllers and the details are reported to the central drug regulator in due course.

As per the new decision, discussed in the Drugs Consultative Committee (DCC) meeting held on June 29, the pharma companies which manufacture products using narcotic and psychotropic substances have to file application in Form 24G and 25G instead of Form 24, informed a DCC member.

According to the draft rules, the pharma companies which are into the narcotics and psychotropic drug manufacturing should apply in Form 24G accompanied by a license fee of Rs 6000 and an inspection fee of Rs 1500 for every inspection or for the purpose of renewal of license.

The new rule also asserts that the manufacturers should furnish various information regarding the purchase and usage of narcotic drugs and psychotropic substances to the CLAA at the time of applying for the licence.

A clause in this regard, which reads as, "Provided further that the license in Form 25G shall furnish a statement of the quantities of Narcotic drugs and Psychotropic substances to the licensing authority and the controlling authority or to such authority as the licensing authority or the controlling authority may direct, both as bulk and formulations, manufactured by him, and of the sales affected by him to the manufacturers, wholesalers, retailers and other outlets for the preceding calendar year within three months of the expiry of the year," will be added to the rule through the amendment.

"The licence shall be deemed to be cancelled or suspended, if the licensee fails to provide the said information in respect of the preceding year by the end of the calendar year," added the draft rule notification.

Currently, the state drug controllers are in charge of monitoring licence, supply chain and manufacturing activities of narcotics and psychotropic products in pharma companies. Each state drug controller has to collect the consumption of these drugs annually from the manufacturers and has to report both the statistics of pervious year and the demand of each raw material by the companies in advance to the DCGI. Considering the request of the companies, the DCGI will allot available quantity of the narcotic drugs and psychotropic substances, which will be collected by the companies from the government-run Opium and Alkaloid factories in Nimach, Madhya Pradesh and Ghazipur, Uttar Pradesh.

However, it is learnt that majority of the state drug controllers in the country are not submitting the annual quota demand and statistics of the consumption of these drugs by the manufacturing firms with the DCGI. The DCGI has expressed his displeasure in this regard in the last DCC meeting, revealed sources.