Health ministry objects to pharma policy proposals


New Delhi: The health ministry has objected to a proposal that will end its role in selecting drugs to be brought under price control and cede control of regulator Central Drugs Standard Control Organization (CDSCO) to the department of pharmaceuticals under the fertilizer and chemicals ministry. 

Health ministry officials are likely to meet their counterparts in the department of pharmaceuticals (DoP) on 30 September to submit their objections to the proposals of the draft pharmaceutical policy. DoP will also meet other stakeholders, including industry experts, this week seeking their suggestions on the draft policy. A group of secretaries in its recommendations to Prime Minister Narendra Modi had in April suggested that department of pharmaceuticals and ministry of AYUSH, which deals with traditional medicines systems, be shifted to the ministry of health and family welfare. The group comprised secretaries from the health ministry, Ayush, health research and pharmaceuticals, among others. 

According to the DoP’s proposed pharmaceutical policy, “all the regulators/commissions pertaining to pharmaceutical industries/sector will be brought under the ambit of one department” to ensure accessibility, affordability of drugs, ease of doing business and more coordinated synergies.

A senior health ministry official said the proposal is unacceptable. “Taking over the reins of CDSCO is in complete contrast to what was suggested to the PM by the group of secretaries. Earlier too, DoP had moved a cabinet note seeking comments on their proposal to take over CDSCO. The health ministry had then too opposed it. The draft policy has further reiterated the same. We will not let it happen,” said a senior health ministry official, requesting anonymity. 

Another recommendation in the draft policy is that DoP will prepare the National List of Essential Medicines (NLEM), which includes list of drugs that are considered essential and should be brought under price caps by National Pharmaceutical Pricing Authority (NPPA). The first such list was released in 1996. That list was subsequently revised in 2003 and the last list that was drawn up in 2015 addressed the issues of changing disease prevalence in the country, besides taking into consideration the new medicines which are now available in India. Proposing to make “drug pricing” more “poor oriented”, DoP in its draft policy suggested that “the DOP will prepare the list of medicines for price regulation and transmit them to NPPA for fixing the price ceilings. The NLEM will remain the basis of the medicines to be brought under price regulation. For social safety, it is necessary that drugs are available at reasonable prices to the common populace. It is more so for India because 65% of the medical costs are on drugs which are out of pocket expenses,” added the draft. 

The Union health ministry currently prepares the list of drugs eligible to be brought under price regulation. The DoP then incorporates NLEM into Schedule 1 of the Drugs (Prices control) Order (DPCO) and then NPPA fixes the prices of drugs in this Schedule. Medicines and devices listed in the NLEM must be sold at the price fixed by NPPA, while those in the non-scheduled list are allowed a maximum annual price hike of 10%. The World Health Organisation (WHO) defines “essential medicines” as those that satisfy the priority health care needs of the population.

“The health ministry deals with patients, medicines and thus it becomes obligatory for us to decide on the drugs that should be eligible for price caps. The drugs listed under price control require huge round of consultations with health experts. This cannot be taken away from the ministry. We have opposed this completely,” added the official.