Drugs Consultative Committee (DCC) sub-committee for Amendments to the Drugs & Cosmetic (D&C) Rules constituted by DCGI and headed by the Karnataka Drugs Controller, Dr BR Jagashetty has taken a decision to focus on four broad segments covering manufacturing, sales, enforcement and drug test labs while revising the Rules. The Sub- committee met at Bengaluru for a two-day session to deliberate on the amendments and the next meeting will be held either in March end or first week of April at Chennai.
The four segments identified are in sync with the present scenario where the industry has undergone considerable transformation to keep pace with the global drug regulatory requirements. The segments were considered keeping in mind public health, business of pharmaceutical and the pharmacy profession. “It has also enabled us provide a time-line of two months within which we intend to complete the job. The panel has begun to study the rules coming under the purview of Sales,” he added.
Among the state drugs controllers present at the meeting were those from Maharashtra, Gujarat, Andhra Pradesh, Nagaland and J&K along with the Tamil Nadu.
“There are 169 Rules and handling each of them is a mammoth task and therefore we arrived at a solution to divide the same into four segments. Wherever required we will change or condense the forms in the Rules,” said Dr Jagashetty.
The Committee will also specifically look into drug testing time schedule which states like Karnataka have been adhering to which is a 15-30 day submission period depending on the stability studies among others. In the existing D&C Rules, there is no indication of a specified period. Therefore, the DCC Sub-Committee has in principle agreed to specify some time period to give the test report by a Government Analyst. However, the rules pertaining to this will be discussed in detail during respective meetings, noted Dr Jagashetty.
In addition, the Amendments to D&C Rules which is now being devised in an age of computerization and networking technology will look at speedy issue licenses in sales and manufacture. In the area of enforcement, the discussion will delve into details keeping in the modernization concepts to nab violators, said Dr Jagashetty.