Generic medicines in India

Medicines account for very high percentage of out-of-pocket expenditures on healthcare in India. The expenditure on medicines as a proportion of outpatient medical expenditure is high as 73 % in rural areas and 68% in urban areas, according to the report “Household Healthcare Utilization & Expenditure in India: State Fact Sheets” published by the Healthcare Financing Division National Health Systems Resource Centre under the Ministry of Health and Family Welfare. Physicians prescribing generic medicines can significantly cut down expenditure on medications, but it has never been enforced despite made mandatory. Ironically, India is the largest exporter of generic drugs. The Clause 1.5 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 prescribes that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drug. The central government informed the parliament that registered medical practitioners have been directed from time to time to comply with these provisions and states have alsobeen advised to ensure prescription of generic drugs and conduct regular prescriptionaudits in public health facilities. Official data provided by the National Pharmaceutical Pricing Authority to the government shows that the total sale of medicines in the country was to the tune of Rs 1.41 lakh crore from April to December last year. Data on sale of generic medicines is, however, not maintained separately by the pricing authority. Awareness on medical ethics code among patients will help them insist on the physicians prescribing generic medicines. Availability and easy access of generic medicines at pharmacies will provide households the options to ask for generic medicines instead of branded medicines. Two key objectives of the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) are: make available quality medicines, consumables and surgical items at affordable prices for all and reduce out-of-pocket expenditure of consumers/patients and to popularize generic medicines among the masses and dispel the prevalent notion that low-priced generic medicines are of inferior quality or are less effective. The Department of Pharmaceuticals have so far opened 9182 Pradhan Mantri Bhartiya Janaushadhi Kendras for sale of generic medicines at affordable prices. The product basket of PMBJP includes 1,759 medicines and 280 surgical devices and covers all major therapeutic groups such as cardiovascular, anti-cancers, anti-diabetics, anti-infectives, anti-allergic, gastro-intestinal medicines, masks, orthopaedic rehabilitation products, surgical dressings, syringes and needles, sanitary napkins, diapers, rubber gloves etc. A medicine available at these outlets is priced based on principle of maximum of 50% of the average price of the top three branded medicines due to which generic medicines are cheaper by at least 50% and in come cases by 80% to 90%. This indicates the quantum of savings the patients can make on their medication bills if more outlets under PMBJP can be opened for easy access to generic medicines. The government has set the target of opening 10,500 PMBJP centres with a target sale of Rs 1200 crore all over the country by 2025. Doubling the amount of incentive to owners of these outlets to Rs 5 lakh given at the rate of 15% of total monthly purchases and additional grant of Rs 2 lakh as one-time special grant for furniture and equipment are expected to help achieve the target. However, the sales target of generic medicine through these outlets compared to total medicine sales being less than one per cent speaks volume about the limitation of increasing sales of generic medicines only through these PMBJP Kendras. Nevertheless, these outlets can play a critical role in popularizing generic medicines towards increasing their demand as prescription medicines. Government data shows that more than 10 lakh people visit these centres and over the past eight years total savings of patients was to the tune of Rs 20000 crore. This indicates growth in sales of generic medicines but there is no room for complacency when the huge market of braded medicines in the country is considered and quantum of out-of-pocket expenditures of patients. The government claims that generic medicines available at PMBJP centres are procured only from World Health Organization-Good Manufacturing Practices (WHO-GMP) and Food Safety and Standards Authority of India (FSSAI) certified suppliers and after two-tier quality assurance by testing at 13 laboratories accredited to the National Accreditation Board for Testing and Calibration Laboratories. Spreading this information can be effective in removing the wrong perception that generic medicines are of inferior quality. State health departments can bolster the awareness drive by spreading these information. While mass awareness can convince people to visit the PMBJP centres, availability of generic medicines at all pharmaceutical outlets will be critical to achieving the key objectives. Physicians prescribing generic medicines is the most crucial factor to bring about a change and this can be possible only through enforcement of the medical ethics code.