The Drugs Technical Advisory Board (DTAB), the highest decision-making authority in the Union health ministry on technical matters, is likely to give its nod for another around 40 fixed dose combination (FDC) drugs which were examined and cleared by the expert panel on FDC that held it first meeting on January 23 and 24. The DTAB, which comprises renowned pharmacologists and the DCGI, is scheduled to meet on February 23.
The expert panel on FDC headed by DCGI met on January 23 and 24 examined a total of 48 combination drugs and most of them were found to be rational. However, DCGI Dr Surinder Singh was not present in the meeting due to his preoccupation with other important official works. The expert panel examined one by one all the 48 combination drugs submitted by the industry. Those who were present in the meeting included renowned pharmacologists and industry association members.
According to sources, the combination drugs which were examined and cleared by the expert panel included the Cardiovasculars category in the DCGI List No. 33 & 216, the Lactobacilliefdcs category in the DCGI List No. 34, 36, 41, 47, 50, 79, 81, 84, 89, 90, 92, 93, 96, 153 & 213, the Antimicrobials in the DCGI List No. 78, 82, 87 & 88, the Anti Ulcerants in the DCGI List No. 152 & 208, the Quinolone category in the DCGI List No. 212, 248, 254, 257, 289, 250 & 255, the Gabapentin combinations in the DCGI List No. 271, the M-S System in the DCGI List No. 3, 5, 6, 8, 104, 105, 117, 132, 191, 192, 237, 238 & 239 and the Topical Drops in the DGCI List No. 256.
In the case of DGCI List No 253 in the Lactobacilliefdcs category, the industry has been asked to submit further details. Besides, the expert panel has asked the industry to submit further data on item No. 164, 165, 166, 253 and 272 in the DCGI list.
With the in-principle approval to another around 40 FDC drugs, the industry and the government have reached a decision on around 180 of the total 294 controversial irrational FDC drugs which the former DCGI Dr Venkateshwarlu wanted to remove from the market. Earlier, in the first DCGI-industry meeting on FDC on July 14 last year, there was consensus among the industry and the government on as many as 138 combination drugs out of these 294 combination drugs.
This was the first meeting of the expert panel which was constituted on October 1 last year to find a lasting solution to the lingering FDC issue. The panel has to examine a total of 156 combination drugs. Now that it has examined 48 drugs, it has still to examine the remaining 108 combinations drugs one by one. The date for the next meeting of the panel has not been finalised. Going by the pace at which the panel is working, it may take more than a year to find a lasting solution to the issue, sources said.