The draft Pharmaceutical Policy looks like it is concentrating more on issues of NPPA. This is evident by the importance of drug pricing given under Para 5.18, stated Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka state drugs controller.
Although the paras right from 5.1 to 5.17 cover the new policy initiatives, more emphasis has been given to drug price mechanisms. This is going by the points indicated in 5.18 which states about the constitution of NPPA, creation of an advisory body to NPPA, responsibilities of NPPA for laying down the price ceilings of selected medicines; ensuring the availability of medicines in adequate quantities, and maintaining a database of information required for fixation of price ceilings. All these are clear indications that draft policy is more focused on pricing, he added.
Under Para 5.18 (e) it is mentioned that ‘Prices once fixed by the NPPA shall not be revised by it unless directed specifically by the government or a higher court’. But this is not right. The need of the hour is to embark on price fixation annually or half yearly as against the current practice of frequent revision, said Dr. Jagashetty.
However on the face of it, this draft policy is a very good move by the government to focus on a several aspects of manufacturing, marketing and skilling of professionals. However, there is a need to include some of the recommendations made by the various committees appointed by the government, he pointed out.
An appreciative aspect is that this draft mentions of a consensus on the need to bring regulators or commissions pertaining to pharmaceutical industry within the ambit of single department. This will ensure that the sector will not have to approach multiple departments with respect to various issues like quality, pricing, patenting, marketing etc. It is high time that Indian pharma sector creates dedicated Ministry of Pharmaceuticals to handle comprehensive areas including commerce, pricing, quality, etc., he said.
The policy clearly highlights manufacture of quality essential drugs accessible at affordable prices, curb unethical practices and restrict loan licensing,. It calls for ‘one company-one drug-one brand name-one price’. It also makes it obligatory for BA/BE studies for all drugs, fix time schedule of 3 months to take final decision on applications, pursue sale of single ingredient drugs by their pharmacopoeial name/ salt name as decided in one of the DTAB meetings. In addition it encourages e-prescription & e-pharmacy which is a step in the right direction, he said.
However to implement these it is essential to bring all the issues under an umbrella of a single department known as the ‘Indian Drugs Administration’ and also to revise the D&C Act and Rules incorporating a separate chapter for pricing, fixing the responsibility for marketers who may be treated on par with manufacturer, supervise State licensing Authorities especially for permissions/approvals of various drugs/formulations including FDCs. Overall the policy is a good move barring the undue importance given to NPPA, said Dr. Jagashetty.