Committee for Amendments to the Drugs & Cosmetic Rules has called for increasing the scope of operations to be able to bring in the new provisions.
The Committee headed by the Karnataka drugs controller Dr BR Jagashetty called for its first meeting here on May 31 and reviewed the possible requirements that were needed to take the task of revising the Drugs and Cosmetic Rules.
In this regard it has recommended to the Drugs Control General of India (DCGI) to include certain terms and references in the order for the Amendments to the Drugs and Cosmetic Rules.
“There is need for more terms and conditions for us to work towards looking at the possible changes to be made. We need to have a complete picture of the issues and challenges of drug regulations across the country to assess the problems region wise,” Dr Jagashetty told Pharmabiz.
There was also discussion that the amendment needs to have a broader perspective with not just Drugs & Cosmetics Rules but also include the Act, he added.
“We have requested for more members in the Committee which would include drugs controllers from the states of Punjab, Andhra Pradesh, Assam and Jammu & Kashmir. Currently the five member team has M Mitra deputy drugs controller CDSCO HQ , New Delhi as the convenor, and Drugs controller, National Capital Territory, Delhi; Commissioner, Food and Drugs Administration, Gujarat; Joint Commissioner, Food and Drugs Administration, Maharashtra as other members. Keeping the interests of the regulatory authorities and industry across the country, we need a national representation in the Committee to look at the various issues to be addressed,” pointed out Dr Jagashetty.
Further, the Committee has also called to widen the scope of categories that need to be inspected and approved. These include stem cell therapies, medical devices and several import regulations which require to be added into the references of the Drugs and Cosmetic Rules.
Discussions were also held to address the clinical research organizations and the test labs which are critical components in the drug development space. With drug tests and patients study reports which are mandated by global regulatory authorities, we need to handle these sectors and ensure that Indian Drugs & Cosmetics Rules and Act have an inclusion of the same, stated Dr Jagashetty.
In addition, the Amendments to the Drugs and Cosmetic Rules would definitely incorporate Good Distribution Practices that would deal with the issue of date expiry drugs which is a key part of the pharmacy trade sector and pharma industry.
Currently there are 169 schedules of the Drugs & Cosmetics Rules and we need to look at each of these segments in detail. This would be enable the Committee to come out the with the Amendments to the Drugs and Cosmetic Rules within a span of six months, stated Dr Jagashetty.