We all are aware of the CDSCO (The Central Drugs Standard Control Organization) work and recently their inspections crackdown the manufacturing and sale of fixed dose combination (FDC) drugs in Uttarakhand without the approval from Drugs Controller General of India (DCGI). CDSCO found two manufacturers who were manufacturing FDC of metformin HCL and teneligliptin hydrobromide hydrate, teneligliptin and pioglitazone HCL, pioglitazone, itraconazole, and terbinafine HCL without approval from Drugs Controller General of India (DCGI) and had approval from the state licensing authority.
Ambic Aayurchem in Roorkee and Mascot Healthcare in Haridwar were involved in the manufacturing of FDC and Uttarakhand Drug Controller canceled their state license on taking action from CDSCO reports. On March 15-16, 2018, CDSCO team along with state drug authority and local police raided premises of both companies and found approximately 10,000 tablets of Betawin- IT (FDC of itraconazole USP (100 mg) + terbinafine HCL BP (250 mg)) worth Rs.3 lakhs on the premises of Mascot. This product is being marketed by Wockhardt Ltd, Mumbai, Medley Pharmaceuticals Ltd, Mumbai, Galpha Laboratories, Nectar Biopharma, Biological E Ltd, Knoll Healthcare, May and Baker Pharma etc. 73 out of 118 products of Mascot were found unapproved by the DCGI. These products are being marketed by Macleods Pharma, Mumbai, Medley Pharmaceuticals, Geno Pharmaceuticals, Goa, Wanbury Ltd, Mumbai, Dr. Morepen Delhi, Wallace Pharma Mumbai etc.
At the premises of Ambic Aayurchem, the team had found one lakh tablets of Tennyl Trio (FDC of metformin hydrochloride IP (500mg) + teneligliptin hydrobromide hydrate equivalent to teneligliptin (20mg)+ pioglitazone hydrochloride equivalent to pioglitazone (15 mg)). The product marketed by Johnlee Pharmaceuticals, Mumbai; Alde Medi Impex Ltd, New Delhi; Vasolif Healthcare, Chandigarh.
The product is marketed by Ambic was also involved in the manufacturing of five new FDCs which were unapproved by DCGI. It was also involved in the manufacturing of nateflinide, metformin HCL and pioglitazone being marketed by United Pharmatech, Mumbai.
After the raids, The state Drugs Controller formed a committee of two-member comprising Gaurav Singh, senior drugs inspector, Haridwar and Neeraj Kumar, drugs inspector, Haridwar to examine manufactured product approval given to the manufacturers in the state and to send a report on FDCs which have not been approved by DCGI.
Uttarakhand Drugs Regulator in a letter stated that the issue of grant of approval of FDCs is being probed by the panel until further orders of state drugs controller, the manufacturing of FDCs approved by Uttarakhand FDA is put on suspension.
In this connection, it is pertinent to mention that combination of two or more drugs i.e. FDC combined for the first time fall under the definition of new drug. The requirements for import, manufacture of new drugs including FDCs were introduced to Drugs and Cosmetics Rules, 1945. Permission from the office of DCGI is required before these are licensed by state licensing authorities (SLAs) for manufacture, sale in the country. The parliamentary standing committee (PSC) on health and family welfare in the 59th report on the functioning of CDSCO observed that some of the state licensing authorities have issued manufacturing licenses for a very large of FDCs without prior clearance from CDSCO. This has resulted in the availability of many FDCs in the market which has not been listed for efficacy and safety. This can put patients at risk.
From time to time, the ministry of health and family welfare has issued directions to the state governments under Section 33P of Drugs and Cosmetics Act to instruct their drugs licensing authorities to refrain from granting licenses for manufacturing of new drugs and FDC. The matter was also discussed in Drugs Consultative Committee meetings, several times.