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Ban on Fixed Dose Combinations MEMBERS' REFERENCE SERVICE LARRDIS LOK SABHA SECRETARIAT, NEW DELHI REFERENCE NOTE No.14/RN/Ref./March/2017 1 For the use of Members of Parliament NOT FOR PUBLICATION BAN ON FIXED DOSE COMBINATION (FDC) DRUGS Prepared by Smt. Sunanda Das Mohanty, Additional Director (23035036) and Shri Rajkumar Patton, Junior Library Assistant of Lok Sabha Secretariat under the supervision of Smt. Kalpana Sharma, Joint Secretary and Dr. P. J. Antony, Director. The reference material is for personal use of the Members in the discharge of their Parliamentary duties, and is not for publication. This Service is not to be quoted as the source of information as it is based on the sources indicated at the end/in the text. BAN ON FIXED DOSE COMBINATION (FDC) DRUGS The Government of India banned 344 Fixed Dose Combination (FDC) drugs on 10 March 20161 citing health reasons and lack of therapeutic justification. FDCs are drugs with two or more active pharmaceutical ingredients combined in a fixed dose to form a single drug2. For over 30 years pharmaceutical companies have been selling these FDCs with scant regard for their efficacy, safety or rationality for use. Process for marketing a drug- Any new drug requires prior approval from the Drugs Controller General (India) [DCGI] before these are licensed by the State Licensing Authorities (SLAs) for manufacture and sale in the country. As FDCs are combinations of certain drugs that are combined together for the first time, these are treated as „New Drugs‟. Many SLAs granted licences to some new FDCs without the approval of the DCG (I) on assessment of safety, efficacy and rationality. This led to availability of a number of FDCs in the Indian market without any knowledge about their safety and efficacy on Indian population. Report of Parliamentary Committee on Health and Family Welfare In their 59th Report, Department-related Parliamentary Standing Committee on Health and Family Welfare observed that some SLAs had issued manufacturing licences for a very large number of FDCs without prior clearance from Central Drugs Standard Control Organization (CDSCO)3 and this had resulted in the 1 Vide Gazette Notifications S.O. Nos. 705(E) to 1048(E). 2 For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent or reduce fever). Cough syrups Phensedyl and Corex, the widely advertised Vicks Action 500, antibiotic combination Zimnic AZ are some of the popular FDCs, which involve commonly used medications such as paracetamol, aceclofenac and nimesulide. 3 CDSCO-(Central Drugs Standard Control Organization )- is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control. 2 availability of many FDCs in the market which had not been tested for efficacy and safety. The Committee had also noted that this could put patients at risk. It pointed out that 'Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk. On an average DCGI is approving one drug every month without trials. This cannot be in public interest by any stretch of imagination.' The Parliamentary Standing Committee expressed the view that those unauthorized FDCs that pose risk to patients and communities, such as a combination of two antibacterials, need to be withdrawn immediately due to the danger of developing resistance that would affect the entire population. (ANNEXURE II). Government’s Action The Government accepted many of the recommendations of the Parliamentary Committee and the Ministry of Health and Family Welfare issued statutory directions to the State Governments to instruct their respective drugs licensing authorities to refrain from granting such licenses. However, the practice was still not discontinued by some of the SLAs. Further, in a letter dated 15 January 2013, the DCGI asked manufacturers to produce safety and efficacy data of their FDC products from the central government or stand the risk of their licences being cancelled. This direction was given for all products approved after 29 September 1988 and before 1 October 2012. Most manufacturers complied only after a lot of hesitation and procedural wrangling, and after several extensions of deadlines and reminders. An 18-month window ending on 14 July 2014 was given for applications from manufacturers justifying the safety, efficacy and rationality of their products. 3 CDSCO also set up 10 professional committees in February 2014 to analyze the rationality as well as safety and efficacy of the FDCs. After careful consideration of the recommendations of the Committee and of the entire matter, the Government issued show cause notices to the manufacturers whose products were found to be irrational. At the request of the manufacturers, additional time of three months was also given to them to respond to the show cause notice. Ultimately, after due consideration of the report and replies, the Government of India banned 344 FDCs on10 March 2016. Following the ban, the drug companies continue to insist on marketing grossly irrational, unsafe and ineffective products. Pharmaceutical companies have teamed up to mount an intense battle with claims that the future of the industry and “Make in India” are threatened. They are doing everything in their power to prevent the government from acting in the public‟s interest. In a major relief to them, the Delhi High Court quashed the Government Ban in December 2016. The Centre has now moved the Supreme Court on 30 January 2017 seeking to enforce the ban once again. It is hoped that the Apex Court will see this as a matter concerning life and death and will not allow any legal “wizardry” by pharmaceutical company counsels. That will be the beginning of the long overdue clean-up of the pharma industry in India. Conclusion As the matter is now before the Supreme Court, it is hoped that it will take into account the serious public health implications of the sale of certain drugs and allow regulatory intervention banning uncertified combination drugs. 4 SOURCES CONSULTED 1. Cleaning Up the Pharma Industry : A Landmark Ban on Irrational Drugs, Economic & Political Weekly, dated: 02.04.2016; vol II no.14 2. Banning of FDC Drugs, PIB 26. 04.2016 3. Fifty-ninth report on the functioning of the central drugs standard control organisation (CDSCO), Rajya Sabha, dated: 08.04.2012 4. 66th Report Action taken by the Government on the recommendations contained in the 59th Report, 2013 5. Gazette notifications (10.03.2016, S.O 705(E) TO 1048(E) on Ban of FDC Drugs, 6. Curb on illegal sale of banned drugs and medicines, Rajya Sabha, starred Question no. 172, dated: 02.08.2016 7. CDSCO establishes 10 expert committies to examine safety of FDCs, Ethics in Clinical Research, dated: 07.02.2014 8. Centre moves SC seeking to enforce ban on 344 fixed-dose-combination drugs, livemint, dated: 30.01.2017 ANNEXURE I LIST OF DRUGS PROHIBITED FOR MANUFACTURE AND SALE THROUGH GAZETTE NOTIFICATIONS UNDER SECTION 26A OF DRUGS & COSMETICS ACT 1940 BY THE MINISTRY OF HEALTH AND FAMILY WELFARE Complete list of 344 drugs banned by the Ministry of Health Family welfare A gazette notification by Ministry of Health and Family Welfare has banned 344 medicines of fixed drug combinations. The Health Ministry banned 344 fixed drug combinations through a gazette notification. The ban, which comes into effect immediately, follows recommendations of an expert committee formed to examine the efficacy of these drug combinations. Here is the complete list of all drug combinations banned by the ministry: 1. fixed dose combination of Aceclofenac + Paracetamol + Rabeprazole 2. fixed dose combination of Nimesulide + Diclofenac 3. fixed dose combination of Nimesulide + Cetirizine + Caffeine 4. fixed dose combination of Nimesulide + Tizanidine 5. fixed dose combination of Paracetamol + Cetirizine + Caffeine 6. fixed dose combination of Diclofenac + Tramadol + Chlorzoxazone 7. fixed dose combination of Dicyclomine + Paracetamol + Domperidone 8. fixed dose combination of Nimesulide + Paracetamol dispersible tablets 9. fixed dose combination of Paracetamol + Phenylephrine + Caffeine 10. fixed dose combination of Diclofenac + Tramadol + Paracetamol 11. fixed dose combination of Diclofenac + Paracetamol + Chlorzoxazone + Famotidine 12. fixed dose combination of Naproxen + Paracetamol 13. fixed dose combination of Nimesulide + Serratiopeptidase 14. fixed dose combination of Paracetamol + Diclofenac + Famotidine 15. fixed dose combination of Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol 16. fixed dose combination of Omeprazole + Paracetamol + Diclofenac 17. fixed dose combination of Nimesulide + Paracetamol injection 18. fixed dose combination of Tamsulosin + Diclofenac 19. fixed dose combination of Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine 20. fixed dose combination of Diclofenac + Zinc Carnosine 21. fixed dose combination of Diclofenac + Paracetamol + Chlorpheniramine Maleate + Magnesium Trisillicate 22. fixed dose combination of Paracetamol + Pseudoephedrine + Cetrizine 23. fixed dose combination of Phenylbutazone + Sodium Salicylate 24. fixed dose combination of Lornoxicam + Paracetamol + Trypsin 25. fixed dose combination of Paracetamol + Mefenamic Acid + Ranitidine + Dicyclomine 26. fixed dose combination of Nimesulide + Dicyclomine 27. fixed dose combination of Heparin + Diclofenac 28. fixed
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