The Press Information Bureau has released a press release on 13th December, 2022 on the voluntary Uniform Code for Pharmaceutical Marketing Practices (UCPMP) for Pharmaceutical companies, which is in operation since 01.01.2015. The Code seeks to prevent unethical practices by the pharmaceutical companies. This code governs the conduct of pharmaceutical companies in their marketing practices, duly covering the various aspects such as medical representatives, textual and audio-visual promotional materials, samples, gifts, etc.
Further, the code establishes relationship with healthcare professionals, wherein the provisions related to travel facilities, hospitality and cash or monetary grants to physicians or their families have been elaborated.
The code also details the mode of operation of the code, responsibilities of the Pharmaceutical Associations in constituting the Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) for handling the complaints and Apex Ethics Committee for Pharmaceutical Marketing Practices (AECPMP) for review, procedure of lodging a complaint, procedure of handling of complaints by the Pharmaceutical Associations and various penalty provisions.
Besides UCPMP, there exists sufficient and enforceable legal regime to counter, control and dis-incentivize the unethical marketing practices. These include provisions under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Income Tax Act, Drugs and Cosmetics Act, Prevention of Corruption Act, etc
Licenses for manufacture, sale and distribution of drugs are granted by the State Licensing Authorities (SLAs) appointed by respective State Governments. Under the Drugs and Cosmetics Rules, 1945 Fixed Dose Combinations (FDC) is a New Drug. For the manufacture of any FDC falling under the definition of New Drug, permission is required from Central Drugs Standard Control Organisation (CDSCO) before obtaining manufacturing license for the New Drug from the concerned State Licensing Authority. Under the Drugs and Cosmetics Act, 1940 manufacture/sale/distribution of any banned drug is a punishable offence. State Licensing Authorities are empowered to take action in this regard.
Some cases of grant of manufacturing license of new drugs including Fixed Dose Combinations (FDCs) by some of the State Licensing Authorities (SLAs) without due approval of the Drugs Controller General (India) [DCG (I)] came to the notice of the Government. Moreover, the Central Government constituted an Expert Committee under the chairmanship of Prof C.K. Kokate to examine the safety and efficacy of such FDCs.
Based on the recommendations of the Prof. C. K. Kokate Expert Committee, the Central Government prohibited 349 FDCs.
However, Supreme Court, vide its order dated 15.12.2017, directed that an analysis be made in greater depth and the cases challenging the ban on (344+5) FDCs which should go to the Drugs Technical Advisory Board (DTAB) and/or a Sub-Committee formed by the DTAB for the purpose of having a relook into these cases.
Accordingly, a Sub-Committee of DTAB was constituted which after providing hearing to all the petitioners/appellants, submitted its report to DTAB which was accepted by DTAB. Based on the recommendations of DTAB, the Central Government prohibited 328 FDCs for manufacture, sale or distribution. The Government also restricted 06 FDCs for manufacture, sale or distribution with certain conditions vide notifications issued on the same date. However, various firms/stakeholders have filed writ petitions in various High Courts across the country including the Hon’ble Supreme Court against the said notifications.