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Date: 2016-10-14 Category: Not Applicable State: Union Government Country: India

Notice Order regarding Examination of Safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from DCG(I)

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This notice pertains to the examination of the safety and efficacy of Fixed Dose Combinations (FDCs) that are licensed for manufacture and sale in India without the prior approval of the Drugs Controller General (India) - DCG(I).
  • The Directorate General of Health Services has reviewed applications from manufacturers regarding these FDCs in consultation with an Expert Committee.
  • Based on this review, decisions have been made regarding the issuance of No Objection Certificates (NOCs) for continued manufacturing and marketing, show cause notices, or letters for conducting Phase IV trials.

Key Changes

  • The notice informs manufacturers that letters containing the decisions related to their applications are ready for dispatch.
  • A list of 283 applicant companies is provided, along with the number of letters pertaining to each company.
  • Akums Drugs & Pharmaceuticals Pvt. Ltd. has the highest number of letters (52).
  • The Pharmaceuticals and Chemicals Travancore Pvt. Ltd. has 16 letters.
  • Tablet (India) Ltd. has 15 letters.
  • Hema Laboratories Pvt. Ltd. has 13 letters.
  • East West Pharma has 12 letters.
  • Cachet Pharmaceuticals Pvt. Ltd. and GKM New Pharma have 11 letters each.
  • Allianz Biosciences Pvt. Ltd., Creative Health Care Pvt. Ltd., Meyer Organics Pvt. Ltd., Swiss Garnier Life Sciences and Safetab Life Sciences have 10 letters each.

Impact Analysis

Impact on Manufacturers

  • Manufacturers required to conduct Phase IV trials will need to plan and execute these trials to generate further data on their products.

Suggested Action Items for Manufacturers

  • Engage with regulatory consultants or experts to ensure compliance with all requirements.

Impact on Regulatory Agencies

  • The Expert Committee may need to review additional data submitted by manufacturers in response to show cause notices.

Key Entities Referenced

Directorate General of Health Services: The government agency responsible for public health in India. Office of Drugs Controller General (India) - DCG(I): The regulatory authority in India responsible for approving drugs and overseeing the pharmaceutical industry. FDCs (Fixed Dose Combinations): Medicines containing two or more active pharmaceutical ingredients (APIs) combined in a single dosage form. Expert Committee: A committee constituted to provide expert advice on the safety and efficacy of FDCs. NOC (No Objection Certificate): A certificate issued by the regulatory authority allowing the continued manufacturing and marketing of a product. Phase IV Trial: Post-marketing studies conducted to gather additional information about a drug's effects in various populations and any side effects associated with long-term use.
Official Source Record View Original Source →
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F. No. 04-01/2013-DC (Misc. 13-PSC) Directorate General of Health Services Office of Drugs Controller General (India) (FDC Division) Dated: 14th October 2016 NOTICE Subject : Examination of safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from DCG(I) This has reference to this Directorate letter of even no. Dated 15.1.2013 on the subject cited above. In this regard, various applications filed by the manufacturers have been examined in consultation with Expert Committee constituted for the purpose. Based on such examination, decisions on the applications for issuance of NOCs for continued manufacturing and marketing/ show cause notices/ letters for conducting Phase IV trial have been taken. Accordingly, these letters have been prepared and are ready for despatch. Details of the applicants with number of such letters against each of these applicants are given below. The concerned applicants can directly collect these letters from ‘CRU’ section. In case, these letters are not collected within stipulated time, same will be despatched through Speed / Registered post. FDC DIVISION 13.10.2016 S.NO. NAME OF COMPANY DOCUMENT 1. M/s. Allianz Biosciences Pvt. Ltd., 10 Letters 2. Akums Drugs & Pharmaceuticals Pvt. Ltd., 52 Letters 3. M/s. Accent Pharma 05 Letters 4. M/s. Aeon Formulations, 19 Letters 5. M/s. Axa Parenterals Ltd., 07 Letters 6. M/s. Anglo-French Drugs & Industries Ltd., 02 Letters 7. M/s. Arius Formulations Pvt. Ltd., 03 Letters 8. M/s. Acron Pharmaceuticals 03 Letters 9. M/s. Alchemist Ltd., 05 Letters 10. M/s. Ajanta Pharma 08 Letters 11. M/s. Argion Cosmed India (P) Ltd., 01 Letter 12. M/s. Avalanche Pharmaceuticals 01 Letter13. M/s. Anphar Organics Pvt. Ltd., 01 Letter 14. M/s. Affy Pharma Pvt. Ltd., 01 Letter 15. M/s. Ahlcon Parenterals (I) Pvt. Ltd., 02 Letters 16. M/s. AtoZ Lifescinces 01 Letter 17. M/s. Acme Lifescinces 07 Letters 18. M/s. Acme Formulations 02 Letter 19. M/s. AASSK Pharmaceuticals 05 Letters 20. M/s. Alkem Laboratories 04 Letters 21. M/s. Abbott Healthcare 05 Letters 22. M/s. Alembic Pharmaceuticals 09 Letters 23. M/s. Aurochem Laboratories (I) Pvt. Ltd., 08 Letters 24. M/s. Arvind Remedies Ltd., 02 Letters 25. M/s. Agio Pharmaceutical Ltd., 04 Letters 26. M/s. Admac Formulations Ltd., 03 Letters 27. M/s. Aayushi Pharmaceuticals Pvt. Ltd., 01 Letter 28. M/s. Aurio Pharm Laboratories 02 Letters 29. M/s. Advanced Vital Enzymes 01 Letter 30. M/s. Adcock Ingram Healthcare 01 Letter 31. M/s. Appasamy Ocular Devices Pvt. Ltd., 01 Letter 32. M/s. Able Pharma Ltd., 01 Letter 33. M/s. Abro Pharmaceuticals Ltd., 02 Letters 34. M/s. Abaris Healthcare Pvt. Ltd., 01 Letter 35. M/s. Bethal Pharmaceuticals 03 Letters 36. M/s. Bonn Schetering Biosciences 09 Letters 37. M/s. BRD Medilabs 09 Letters 38. M/s. Biogenetic Drugs Pvt. Ltd., 06 Letters 39. M/s. Bidhan Pharmaceuticals 03 Letters 40. M/s. Biomaarks Drugs India Pvt. Ltd., 05 Letters 41. M/s. Befam Pharmaceuticals Pvt. Ltd., 01 Letter 42. M/s. Bionext Pharma Pvt. Ltd., 01 Letter 43. M/s. BACTEC Pharmaceuticals 01 Letter 44. M/s. Bal Pharma Ltd., 01 Letter45. M/s. Brassica Pharma Pvt. Ltd., 01 Letter 46. M/s. BDH Industries Ltd., 01 Letter 47. M/s. BHC Lab Pvt. Ltd., 02 Letters 48. M/s. Burnet Pharmaceuticals Pvt. Ltd., 02 Letters 49. M/s. Centaur Pharmaceuticals Pvt. Ltd., 09 Letters 50. M/s. Cachet Pharmaceuticals Pvt. Ltd., 11 Letters 51. M/s. Creative Health Care Pvt. Ltd., 10 Letters 52. M/s. Cris Pharma (I) Ltd., 04 Letter 53. M/s. Cipla Ltd., 02 Letters 54. M/s. Cosmo Life Sciences 03 Letters 55. M/s. Curetech Skincare 02 Letters 56. M/s. Cradel Pharmaceuticals Pvt. Ltd., 03 Letters 57. M/s. CU-V-Kar Genetics 02 Letters 58. M/s. Cian Healthcare Ltd., 01 Letter 59. M/s. Central Drugs and Pharmaceuticals 06 Letters 60. M/s. Crescent Therapeutics Ltd., 01 Letter 61. M/s. Caplet India Pvt. Ltd., 02 Letters 62. M/s. Cotec Healthcare Pvt. Ltd., 01 Letter 63. M/s. Corona Remedies Pvt. Ltd., 01 Letter 64. M/s. Cheryl Laboratories Pvt. Ltd., 01 Letter 65. M/s. Chinubhai Pharma Pvt. Ltd., 01 Letter 66. M/s. Consern Pharma (I) Pvt. Ltd., 01 Letter 67. M/s. Daeiou Pharmaceuticals (P) Ltd., 05 Letters 68. M/s. D.M. Pharma 05 Letters 69. M/s. Diamond Drugs Pvt. Ltd., 03 Letters 70. M/s. Darwin Formulations Pvt. Ltd., 02 Letters 71. M/s. Dynamic Organics Life Sciences Pvt. Ltd., 05 Letters 72. M/s. Dusap Pharmaceuticals 01 Letter 73. M/s. Dagon Pharmaceuticals Pvt. Ltd., 04 Letters 74. M/s. D.R. Johns Pvt. Ltd., 03 Letters 75. M/s. Deepin Pharmaceuticals Pvt. Ltd., 02 Letters76. M/s. Dabur India Ltd., 01 Letter 77. Dr. Miltons Laboratories Pvt. Ltd., 03 Letters 78. M/s. Dallas Formulations Ltd., 01 Letter 79. M/s. Dr. Sains Laboratories 01 Letter 80. M/s. Encube Ethicals Pvt. Ltd., 06 Letters 81. M/s. East African (I) Overseas 03 Letters 82. M/s. Elder Pharmaceuticals Ltd., 02 Letters 83. M/s. Elder Healthcare Ltd., 01 Letter 84. M/s. Eskag Pharma Pvt. Ltd., 03 Letters 85. M/s. Eucare Pharmaceuticals Pvt. Ltd., 02 Letters 86. M/s. Emcee Pharmaceuticals (P) Ltd., 04 Letters 87. M/s. East India Pharmaceuticals Works Ltd., 04 Letters 88. M/s. Embiotic Laboratories (P) Ltd., 03 Letters 89. M/s. East West Pharma 12 Letters 90. M/s. Elan Pharma (I) Pvt. Ltd., 01 Letter 91. M/s. Everest Formulations 03 Letters 92. M/s. Eisen Pharmaceuticals ltd., 01 Letter 93. M/s. Esteem Lab Pvt. Ltd., 02 Letters 94. M/s. Emcure Pharmaceuticals Ltd., 01 Letter 95. M/s. Fourrts (India) Laboratories Pvt. Ltd., 01 Letter 96. M/s. Franco-Indian Remedies Pvt. Ltd., 01 Letter 97. M/s. Goodman Pharmaceuticals 09 Letters 98. M/s. GKM New Pharma 11 Letters 99. M/s. Geno Pharmaceuticals Ltd., 05 Letters 100. M/s. Galpha Laboratories Ltd., 03 Letters 101. M/s. Glenmark Pharmaceuticals Ltd., 03 Letters 102. M/s. Gurufcure, 02 Letters 103. M/s. Gopaldas Vishram Co Ltd., 01 Letter 104. M/s. GlaxoSmithKline Pharmaceuticals Ltd., 01 Letter 105. M/s. Glenwell Pharma 01 Letter 106. M/s. Garima healthcare Pvt. Ltd., 01 Letter 107. M/s. Hiral Labs Ltd., 01 Letter108. M/s. Huntra Labs 02 Letters 109. M/s. Herb Edge Healthcare Pvt. Ltd., 02 Letters 110. M/s. Healkraft Pharma (I) Pvt. Ltd., 01 Letter 111. M/s. Healers Lab 02 Letters 112. M/s. Helios Pharmaceuticals 01 Letter 113. M/s. Hema Laboratories Pvt. Ltd., 13 Letters 114. M/s. HeSa Pharmaceuticals 03 Letters 115. M/s. Harson laboratories 01 Letter 116. M/s. Hygeia Pharmaceuticals Mfg. (P) Ltd., 01 Letter 117. M/s. Indi Pharma Pvt. Ltd., 01 Letter 118. M/s. Indoco Remedies Ltd., 01 Letter 119. M/s. Indchemie Health Specialities Pvt. Ltd., 02 Letters 120. M/s. IPCA Laboratories Ltd., 06 Letters 121. M/s. Inga Laboratories Pvt. Ltd., 03 Letters 122. M/s. Japshi Chem Pharmaceuticals 05 Letters 123. M/s. J.R. Pharmaceuticals 02 Letters 124. M/s. Jubilant Pharmaceuticals Pvt. Ltd., 01 Letter 125. M/s. J’s Laboratories (P) ltd., 02Letters 126. M/s. Juggat Pharma 01 Letter 127. M/s. Khandelwal Laboratories Pvt. Ltd., 04 Letters 128. M/s. Kaizen Pharmaceuticals 07 Letters 129. M/s. Krebz Healthcare (P) Ltd., 03 Letters 130. M/s. Knox Life Sciences 04 Letters 131. M/.s Kaptab Pharmaceuticals 01 Letter 132. M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., 01 Letter 133. M/s. Kamron Laboratories Ltd., 02 Letters 134. M/s. Karlin Pharmaceuticals and Exports Pvt. Ltd., 02 Letters 135. M/s. Klar Sehen Pvt. Ltd., 01 Letter 136. M/s. Logos Pharma 1 Letter 137. M/s. Lark Laboratories India Ltd., 01 Letter 138. M/s. Livin Formulations 04 Letters139. M/s. Life Line Pharma 03 Letters 140. M/s. Lyra Laboratories Pvt. Ltd., 05 Letters 141. M/s. Laborate Pharmaceuticals India Ltd., 02 Letters 142. M/s. Leben Laboratories Pvt. Ltd., 01 Letter 143. M/s. Lincoln Pharmaceuticals Ltd., 01 Letter 144. M/s. Lustre Derma Care 01 Letter 145. M/s. Laboratories Griffon Pvt. Ltd., 04 Letters 146. M/s. Lessac Research Laboratories Pvt. Ltd., 01 Letter 147. M/s. Lok-Beta Pharmaceuticals India Pvt. Ltd., 01 Letter 148. M/s. Libra Drug (India) 01 Letter 149. M/s. MC Riyavin Bio-Research 01 Letter 150. M/s. Mercury Laboratories Ltd., 03 Letters 151. M/s. Maneesh Pharmaceuticals Ltd., 03 Letters 152. M/s. Mascot Health Series Pvt. Ltd., 09 Letters 153. M/s. Meyer Organics Pvt. Ltd., 10 Letters 154. M/s. Med Manor Organics Pvt. Ltd., 08 Letters 155. M/s. MDC Pharmaceuticals (P) Ltd., 08 Letters 156. M/s. Marien Pharmatech Pvt. Ltd., 02 Letters 157. M/s. Madras Pharmaceuticals 05 Letters 158. M/s. Moraceae Pharmaceuticals Pvt. Ltd., 06 Letters 159. M/s. Micro Labs Ltd., 05 Letters 160. M/s. Medibest Pharma Pvt. Ltd., 03 Letters 161. M/s. Morepen Laboratories Ltd., 02 Letters 162. M/s. Mepromax Lifesciences Pvt. Ltd., 03 Letters 163. M/s. Mistair Health & Hygiene Pvt. Ltd., 01 Letter 164. M/s. Mediforce Health Care Pvt. Ltd., 02 Letters 165. M/s. Maxtar Biogenics 02 Letters 166. M/s. Millennium Herbal Care Ltd., 01 Letter 167. M/s. Midas Care Pharmaceuticals Pvt. Ltd., 02 Letters 168. M/s. Medipol Pharmaceuticals 01 Letter 169. M/s. Medeor Pharma Pvt. Ltd., 01 Letter170. M/s. Mendine Pharmaceuticals Pvt. Ltd., 03 Letters 171. M/s. Marien Pharmatech Pvt. Ltd., 01 Letter 172. M/s. Marc Laboratories Ltd., 01 Letter 173. M/s. Mamta Pharmaceuticals 01 Letter 174. M/s. Macleods Pharmaceuticals Ltd., 01 Letter 175. M/s. Mediguard Remedies 01 Letter 176. M/s. Noel Pharma India Pvt. Ltd., 09 Letters 177. M/s. National Pharmaceuticals 03 Letters 178. M/s. Naxpar Pharma Pvt. Ltd., 05 Letters 179. M/s. NANZ Med Science Pharma (P) Ltd., 01 Letter 180. M/s. Next Wave India 01 Letter 181. M/s. NTK Pharma 01 Letter 182. M/s. ONEX Life Science Pvt. Ltd., 01 Letter 183. M/s. Orbit Life Sciences Pvt. Ltd., 07 Letters 184. M/s. Ontop Pharmaceuticals Pvt. Ltd., 01 Letter 185. M/s. Psychotropics India Pvt. Ltd., 07 Letters 186. M/s. Pro Laboratories Pvt. Ltd., 07 Letters 187. M/s. Pro-Laboratories Pvt. Ltd., 04 Letters 188. M/s. Pharma Synth Formulations Ltd., 07 Letters 189. M/s. Promed Laboratories Pvt. Ltd., 03 Letters 190. M/s. Panacea Biotech Ltd., 03 Letters 191. M/s. Pristine Lifescinces 04 Letters 192. M/s. Pulse Pharmaceuticals Ltd., 01 Letter 193. M/s. PURO-Pharma Laboratories 01 Letter 194. M/s. Pegasus Farmaco India Pvt. Ltd., 01 Letter 195. M/s. Piramal Enterprises Ltd., 01 Letter 196. M/s. Pharmafabricon, 01 Letter 197. M/s. Pilco Healthcare Pvt. Ltd., 01 Letter 198. M/s. Parker Robinson Pvt. Ltd., 02 Letters 199. M/s. Preet International Pvt. Ltd., 02 Letters 200. M/s. Prakruti Products Pvt. Ltd., 01 Letter 201. M/s. P & B Laboratories Ltd., 01 Letter202. M/s. Parnax Lab Ltd., 01 Letter 203. M/s. Pfizer Ltd., 01 Letter 204. M/s. Surien Pharmaceuticals (P) Ltd., 01 Letter 205. M/s. Sarvotham Care Ltd., 01 Letter 206. M/s. Symbiotic Drugs & Diabetic Care Pvt. Ltd., 01 Letter 207. M/s. Stedman Pharmaceuticals Pvt. Ltd., 06 Letters 208. M/s. Shreya Life Sciences Pvt. Ltd., 02 Letters 209. M/s. Skan Research Labs Pvt. Ltd., 05 Letters 210. M/s. Savi Pharma 02 Letters 211. M/s. Saichem Parenterals Pvt. Ltd., 01 Letter 212. M/s. Santo Formulations 01 Letter 213. M/s. Sankalp Healthcare & Allied Products Pvt. Ltd., 01 Letter 214. M/s. SKN Organics Pvt. Ltd., 01 Letter 215. M/s. Softgel Healthcare Pvt. Ltd., 01 Letter 216. M/s. Selvok Pharmaceuticals Co., 01 Letter 217. M/s. Sterile Gene Life Sciences (P) Ltd., 01 Letter 218. M/s. Suraksha Pharma Pvt. Ltd., 02 Letters 219. M/s. Sunways (India) Pvt. Ltd., 02 Letters 220. M/s. Sunglow Pharmaceuticals Pvt. Ltd., 02 Letter 221. M/s. Strassenburg Pharmaceuticals Ltd., 03 Letters 222. M/s. Swastik Pharmaceuticals 02 Letters 223. M/s. Salute Bestochem 03 Letters 224. M/s. Shiva Biogenetic Pharmaceuticals Pvt. Ltd., 06 Letters 225. M/s. Scott-Edil Pharmacia Ltd., 03 Letters 226. M/s. Sain Medicaments Pvt. Ltd., 04 Letters 227. M/s. Sayora Pharma Pvt. Ltd., 03 Letters 228. M/s. Syncom Healthcare Ltd., 09 Letters 229. M/s. Sun Pharma Drugs Pvt. Ltd., 03 Letters 230. M/s. Sun Pharmaceuticals Industries Ltd., 02 Letters 231. M/s. SAF Fermion Ltd., 05 Letters 232. M/s. SAAR Biotech 09 Letters 233. M/s. Synokem Pharmaceuticals Ltd., 07 Letters234. M/s. Swiss Garnier Life Sciences 10 Letters 235. M/s. Suncare Formulations Pvt. Ltd., 05 Letters 236. M/s. Sunrise International Labs Ltd., 01 Letter 237. M/s. Safetab Life Sciences 10 Letters 238. M/s. Smilax Heatlh Care Pvt. Ltd., 04 Letters 239. M/s. Sanzyme Ltd., 01 letter 240. M/s. Serin Formulations Pvt. Ltd., 01 Letter 241. M/s. Restech Pharma 07 Letters 242. M/s. Resilient Cosmeceuticals Pvt. Ltd., 03 Letters 243. M/s. Ravian Life Sciences Pvt. Ltd., 05 Letter 244. M/s. RPG Life Sciences 02 Letters 245. M/s. Res Sancta, 08 Letters 246. M/s. Rivpra Formulation Pvt. Ltd., 05 Letters 247. M/s. Ricker Pharmaceuticals Pvt. Ltd., 04 Letters 248. M/s. Ravenbhel Healthcare Pvt. Ltd., 05 Letters 249. M/s. Reltsen Health Care 05 Letters 250. M/s. Retort Laboratories 01 Letter 251. M/s. Tanmed Pharmaceuticals 04 Letters 252. M/s. Tychos Therapeutics Pvt. Ltd., 06 Letters 253. M/s. Themis Medicare Ltd., 02 Letters 254. M/s. The Pharmaceuticals and Chemicals Travancore Pvt. Ltd., 16 Letters 255. M/s. Tirupati Medicare Ltd., 07 Letters 256. M/s. The Madras Pharmaceuticals 02 Letters 257. M/s. Tristar Formulations Pvt. Ltd., 03 Letters 258. M/s. Tablet (India) Ltd., 15 Letters 259. M/s. Unichem Laboratories Ltd., 01 Letter 260. M/s. Unibiotech Formulations 06 Letters 261. M/s. Unix Biotech 10 Letters 262. M/s. Unique Biotech Ltd., 04 Letters 263. M/s. Unimarck Pharma (India) Ltd., 03 Letters 264. M/s. Unijules Life Sciences Ltd., 03 Letters 265. M/s. UCB India Pvt. Ltd., 01 Letter 266. M/s. Universal Twin Labs 03 Letters267. M/s. Unicure (India ) Pvt. Ltd., 02 Letters 268. M/s. Universal Pharmaceuticals Ltd., 02 Letters 269. M/s. Vance & Health Pharmaceuticals Pvt. Ltd., 05 Letters 270. M/s. Vivimed Labs Ltd., 05 Letters 271. M/s. Valence healthcare 04 Letters 272. M/s. V.G.I. Pharma Pvt. Ltd., 01 Letter 273. M/s. Visa Drugs & Pharmaceuticals 01 Letter 274. M/s. Vapi Care Pharma 01 Letter 275. M/s. Wallace Pharmaceuticals Ltd., 05 Letters 276. M/s. Windlas Biotech Ltd., 11 Letters 277. M/s. Wockhardt Ltd., 03 Letters 278. M/s. Win Medicare Pvt. Ltd., 02 Letter 279. M/s. Yash Pharma Laboratories Pvt. Ltd., 01 Letter 280. M/s. Yash Pharma Laboratories 05 Letters 281. M/s. Yash Medicare Pvt. Ltd., 02 Letters 282. M/s. Zuventus Healthcare Ltd., 04 Letters 283. M/s. Zim Laboratories 02 Letters

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