The Union health ministry has moved Supreme Court, praying it to club and transfer all the petitions pending in various High Courts in the country filed by a large number of pharma companies and associations against the ministry’s ban on 344 fixed dose combination (FDC) drugs in March this year.
According to sources, the ministry’s move in this regard is to avoid any kind of ambiguity on the issue that could arise from differing verdicts that might come from different High Courts as the case is pending in around 10 High Courts including Delhi High Court where the case has already been heard and an order is expected any time. It its petition, the ministry has requested the Supreme Court that all cases against the ban order being heard in High Courts across the country should be transferred to Supreme Court and be heard as a single case.
Earlier on March 12, 2016, the Union health ministry had prohibited 344 FDC drugs, taking the pharma industry by surprise. Several major multinational companies and Indian companies were affected by the ban of these FDC drugs including widely sold pain-killers, anti-diabetics and respiratory therapies. Subsequently, hundreds of petitions were filed by the drug makers in various High Courts against the health ministry’s prohibition order.
The ministry prohibited the 344 FDC drugs for human use under section 26 A of Drugs and Cosmetics Act (D&C Act) 1940 as the government felt that the use of these drugs are likely to involve risk to human beings whereas safer alternatives to the said drug are available. The government’s decision to ban these drugs was based on the recommendations of an Expert Committee constituted by the ministry some time back.
The matter has been examined by an Expert Committee appointed by the Central Government and the said Expert Committee recommended to the Central Government that the said drug is found to have no therapeutic justification, the ministry had said.
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Drugs and Cosmetics Act – Lesson 4 – Schedules Y
Rules and Permissions
122A – To Import New Drugs
122B – To Manufacture New Drugs
122D – To import or manufacture fixed dose combinations
122DA – To conduct clinical trials for new drug/investigational new drug
122DAA – Definition of Clinical Trial
122DD – Registration of Ethics Commitee
122E – Definition of New Drug
Appendices of Schedule Y
Appendix I. Data to be submitted along with the application to conduct clinical trial/import/manufacture of new drugs for marketing in the country
Appendix IA. Data to be submitted along with the application to conduct clinical trial/import/manufacture of new drugs already approved in the country
Appendix IB. Data to be submitted along with the application to conduct clinical trial or import or manufacture of a Phytopharmaceutical Drug in the Country
Appendix II. Structure, Contents and Format for Clinical Study Reports
Appendix III. Animal Toxicology (Non-Clinical Toxicology Studies)
Appendix IV. Animal Pharmacology
Appendix V. Informed Consent
Appendix VI. Fixed Dose Combinations (FDC)
Appendix VII. Undertaking by the Investigator.
Appendix VIII. Ethics Committee
Appendix IX. Stability testing of new drugs
Appendix X. Contents of the Proposed Protocol for Conducting Clinical Trials
Appendix XI. Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial
The union health ministry’s expert panel, constituted for the massive exercise of examining and regularising the thousands of fixed dose combinations (FDCs) permitted for manufacture and sale in the country without due approval from the Drugs Controller General of India (DCGI), will hold its fourth meeting on June 11 to scrutinise several FDC applications filed by different pharma companies.
The expert panel, set up by the CDSCO following the huge number of applications, running over 5000, has already held three meetings and examined several FDC drugs. The experts who will be examining the 15 FDC drugs on June 11 included Dr Renuka Kulkarni Munshi, Dr Iqbal Kaur, Dr Subhash Giri, Dr Niranjan Mohanty and Dr B Gupta.
The panel will assess the efficacy and safety profile and presentations filed by these companies before taking any final decision. After the DCGI asked the industry to prove the efficacy of the FDCs permitted by the SLAs without concurrence of the DCGI, thousands of applications came to the DCGI office. The authorities then set up a committee to work out the modalities on how to examine the applications as there were not guidelines and norms in this regard.
The panel will go through the applications for the FDC products filed by Hetero Labs (azithromycin 125mg/250mg/500mg + cefixime 100mg/200mg/200mg tablets); Valence Healthcare (cefixime (as trihydrate) 200mg +azithromycin drihydrate IP 250mg film coated tablets); Relax Pharmaceuticals (cefixime 200/200mg + azithromycin 250/500mg tablet); East West Pharma (cefixime trihydrate IP 200mg +azithomycin dihydrate IP 500mg film coated tablets); FDC Ltd (cefixime 100mg +azithromycin 125mg dispersible tablets); and Akums Drugs & Pharmaceuticals Ltd (azithromycin 250mw500mg +cefixime 200mg tablets).
The panel will also examine the FDC applications filed by MDC Pharmaceuticals (cefixime IP eg. to anhydrous cefixime 200mg +acetyl cysteine USP 300mg film coated tablets); Akums Drugs & Pharmaceuticals (cefixime IP eg. to anhydrous cefixime 400mg +levofloxacin hemihydrate IP eq. to levofloxacin 500mg tablets); Talent Healthcare (cefpodoximc proetile IP 200mg +azithromycin dihydrale IP 250mg film coated tablets); Macleods Pharmaceuticals (cefpodoxime proxetil 200mg +azithromycin 250mg film coated tablets); Aeon Formulations (cefpodoxime 320mg +azithromycin 500mg tablets, and cefpodoxine 100mg +azithromycin 125mg dispersible tablet); and Orbit Lifesciences (azithromycin dihydrate lP eq. to azithromycin 250mg/500mg +cefpodoxime proxetil IP eq. to cefpodoxime 200mg film coated tablets, and cefpodoxime proxetil 200 mg + dicloxacillin sodium 500 mg tablets).
The list also include Relax Pharmaceuticals (cefpodoxine proxetil 200 mg + levofloxacin hemihydrate 250 mg tablets); Akums Drugs & Phannaceuticals (levofloxacin 250mg/500mg +azithromycin 250mg/500mg tablets);Gelnova Laboratories (anhydrous azithromycin 250mg/500mg +anhydrous levofloxacin 250mg/500mg tablets); Synokem Pharma (azithromycin 250 mg/500 mg + levofloxacin 250 mg/500 mg film coated tablet); Hetero Labs (azithromvcin 250mg/500mg +levofloxacin 250mg/500mg tablets); Arion Healthcare (beclomthasone dipropionate O.025%w/v + clotrimazole l%w/v +chloramphenicol 5%w/v +gentamycin sulphate 0.3%w/v + lignocaine HCI 2%w/v ear drops); Aeon Formulations (ciprofloxacin HCI IP 250mg +phenazopyridine HCI USP 200mg film coated tablets); Alembic Pharmaceuticals (roxithromycin IP 150mg +serratiopeptidase 10mg film coated tablets); Akums Drugs & Pharmaceuticals (sulphadiazine sodium 100 mg + trimethiprim 20 mg oral powder); and Bushal Healthcare (trimethoprim IP 200mg +sulphadiazine IP 1000mg uncoated tablets).
Thousands of FDC drug manufacturers in the country engaged in production of drugs licensed prior to September 21, 1988, can now heave a sigh of relief as the Drugs Controller General of India (DCGI) has excluded such drugs from the requirement of proving the safety and efficacy of FDC drugs licenced by the SLAs without due approval from the DCGI.
On January 15 last year, the DCGI had asked the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and had made it clear that those FDCs approved by the State licencing authorities (SLAs) from October without the permission of the DCGI will be considered for ban.
“An issue has been raised regarding applicability of above requirements for FDCs licensed by State licencing authorities before 21.09.1988, after which all relevant provisions relating to New Drugs were introduced in Drugs and Cosmetics Rules. The matter has been considered by this office and it is hereby clarified that requirements of providing safety and efficacy as mentioned above is not applicable for such FDCs which are licensed prior to 21st September 1988”, DCGI Dr GN Singh clarified in a letter addressed to all the state drug controllers in the country.
The DCGI’s clarification comes at a time when the DCGI’s office is conducting the massive exercise of examining the rationality of thousands of FDCs permitted by the SLAs without due approval from the DCGI.
The union health ministry had earlier constituted expert panels for the exercise of examining and regularising the thousands of fixed dose combinations (FDCs) permitted for manufacture and sale in the country without due approval from the DCGI. The expert panels have already held three meetings and the fourth meeting is scheduled for June 11.
The seminar on this issue is significant as the recent methodology adopted by the regulatory authorities in scrutinising the fixed dose combinations (FDCs)’s rationality has created extreme discomfort in the pharma industry. The current requirements spelt out by the DCGI office in terms of submitting efficacy and safety data was a major concern for the drug manufacturers, especially the small and medium pharma manufacturers in the country.
For the pharma industry, FDCs are a vital contributor to overall business and business growth. The SLA-approved FDCs have been dominating the Indian pharma space and have been well accepted by the medical professionals as well. However, the recent requirements spelt out by the DCGI office have played the spoilsport for the pharma industry in the country.
The seminar is intended to enlighten on the relevance of FDCs vis-à-vis the global practices, in the light of patients’ acceptability and understand whether there are any hurdles (real or virtual) faced by medical professionals in prescribing the same.
Drugs Controller General of India (DCGI) Dr GN Singh will be the chief guest in the seminar. Dr VG Somani, Joint Drugs Controller (India) – CDSCO(Delhi), will be the guest of honour, while Dr K Bangarurajan, Deputy Drugs Controller (India) – CDSCO West Zone (Mumbai) will be the special guest of the seminar.