Editorial

Revisiting India’s drug pricing framework

The rising cost of medicines in India is severely eroding household savings, causing immense difficulties for many low- and middle-income families in continuing the treatment of family members.

Sentinel Digital Desk

The rising cost of medicines in India is severely eroding household savings, causing immense difficulties for many low- and middle-income families in continuing the treatment of family members. The Parliamentary Standing Committee on Chemicals & Fertilisers has pointed out that many commonly prescribed medicines for everyday and long-term health issues are being sold at high prices because of unfair profit margins, and that there is still a need to fix the rules about how these medicine prices are set. Failure to curb exorbitant prices of medicines will only make the country’s heavy burden of chronic and common diseases grow heavier and make recovery harder for many households. The Ministry of Chemicals & Fertilizers (Department of Pharmaceuticals), however, insists that the high trade margin is not the industry norm but is observed only in the case of a small fraction of the market. It also says that the National Pharmaceutical Pricing Authority (NPPA) has been working to lower high trade margins, which includes setting price limits on 106 non-scheduled drug formulations in 2014, made up of 22 diabetes and 84 heart disease drugs; capping trade margins at 30% for 42 selected non-scheduled cancer medicines; and reducing trade margins by about 50% on 526 brands of medicines, leading to annual savings of Rs. 984 crore. The statistics, however, cannot hide the harsh reality of high prescription drug prices raising out-of-pocket expenditure for patients. Since medicine costs make up 60-70% of overall treatment expenses in India, rising medicine prices push treatment costs sharply upward, making even basic care for common and chronic ailments unaffordable for millions of people. The parliamentary panel, however, found the Ministry’s explanation inadequate and believes it fails to address the committee’s concerns about the apparent lack of control over trade margins, especially for non-scheduled drugs, which the committee insists allows for widespread profiteering at patients’ expense. The National Pharmaceutical Pricing Policy (NPPP) of 2012 provides the regulatory framework for drug pricing through the Drugs (Prices Control) Order, 2013 (DPCO, 2013). Prices of scheduled drugs are strictly controlled under this framework but medicine companies are free to set the prices of non-scheduled drugs and only a cap of 10% on annual increase is applied. The committee pointed out with concern that a significant portion of the pharmaceutical market, approximately 82%, comprises non-scheduled drugs and thus, remains outside the ambit of direct price control. This reality check led the panel to reiterate its recommendation for revisiting the existing mechanism, which currently only monitors annual MRP increases of up to 10% for non-scheduled drugs, to mitigate the adverse impact on patients, particularly those requiring care for chronic ailments and life-saving medications. Without increasing the affordability of treatment, simply intensifying awareness campaigns about early screening and the continuation of treatment to reduce the disease burden of diabetes, heart disease, hypertension, asthma, and other conditions will not ensure an improvement in people’s health. The delay in dealing with the Trade Margin Rationalisation suggested by the Committee is due to a long wait in finalising the plan, with many pharmaceutical companies ready to accept it, but some MSMEs are worried that this approach could harm their interests, lead to job losses, and affect the supply of medicines to remote areas. The firm view taken by the committee that while it is important to address the concerns of MSMEs and pharmaceutical manufacturers, the objective of providing medicines at affordable prices for the common man, must remain paramount and should not suffer due to prolonged deliberation by the Ministry with the stakeholders set the tone of parliamentary guidance on fixing prices of medicines for common and chronic ailment. The government argues that one of the key principles for regulating drug prices under the NPPP, 2012, is the drug’s essentiality. The Ministry’s submission to the parliamentary panel highlights that “Essentiality” criteria for drugs is met by considering the medicines specified in the National List ofEssential Medicines (NLEM) released and revised by Ministry of Health and Family Welfare from time to time. The NLEM includes medicines that address the priority health needs of the country’s population and must be made available at all times in adequate quantities within a functioning health system to serve the general public. Only the expansion of this list and a review of the drug-pricing framework recommended by the Committee can prevent medicine prices from spiralling.