The 48th session of the Drugs Consultative Committee (DCC) to be held on July 24, 2015 at New Delhi is gearing up to deliberate on concerns and proposals put forth by state licensing authorities (SLAs) to create an efficient and transparent regulatory environment.

There is also a separate set of suggestions put forth by the various SLAs including Maharashtra, Goa, Odhisha.

The session which is to be chaired by Dr. GN Singh, Drugs Controller General of India will have Central Drugs Standard Control Organisation (CDSCO)  along with the Directorate General of Health Services and ministry of health and family welfare to be part of the deliberations.

To begin with the discussions are expected to be about export and sale of medicines through web portals which is a violation of the Drugs and Cosmetics Act & Rules as of now.

SLAs have insisted the need to prescribe time limit for government laboratories to furnish test reports. They are concerned about the stipulated timelines followed by CDL, Kolkata which ranges from 60 -90 days using HPCL testing or normal chemical testing processes in a casual manner.

It is learnt that there are a few other requests put forth and among these the spotlight would be on: details of production, consumption, import and export of psychotropic substances to the International Narcotics Control Board (INCB), Vienna; norms to loan licensee manufacturing recombinant products with specified timelines; ensuring safety, efficacy and quality aspects; strict monitoring of diclofenac injection in animals to stop poisoning in vulture population which impacts humans, focus on trafficking codeine preparations within India and to the South Asian region.

Further, SLAs have called to regulate nicotine replacement therapy through e-cigarettes, chewing gum and lozenges which are sold over-the-counter. The proposal is to include it under Schedule H, besides adopt a uniform inspection methodology for manufacturing units.

There is also a need to develop a software to record Schedule H-1 drugs to be maintained as a part of the computerized cash or credit memos rather than maintain separate registers for the same. Another issue is about inclusion of formulations containing lorazepam, clonazepam and similar psychotropic drugs under the list of Schedule H-1 drugs.

The SLAs have also felt the need to bring in manufacturers and marketing agencies of mehandi or henna paste sold in cones and packets to come under the ambit of D&C Act due to several allergic reactions reported.

SLAs have also emphasized to devise a drug inspectors training module in an effort to maintain consistent and uniform implementation of the D&C Act and Rules throughout the country.