Three major pharmaceutical associations of the country, IDMA, IPA and OPPI, have sent a joint memorandum to the Union Health Secretary seeking his immediate intervention in the FDC issue.
Pharmaceutical units wanted to continue production of 150 combinations classified as 'need further examination' and another 19 as 'decision taken' after the October 27 meeting but DCGI wanted production of 294 combinations including these 169 to be discontinued forthwith.
In a letter dated October 30, 2007, these associations have sought immediate intervention of Union Health secretary Naresh Dayal to solve the issue of whether to continue the production of the 150 'need further examination' and 19 'decision taken' category drugs. Since the DCGI is yet to fully examine the 150 drugs, the industry should be allowed to continue production of these drugs till the examination is completed and a decision is taken thereon to approve or reject the drug, the associations pleaded in the memorandum.
The letter said, "We seek your intervention (a) to resolve the issue of Fixed Dose Combinations (FDCs) approved by the State Licensing Authorities (SLAs) without the requisite No Objection Certificate (NOC) from the Office of the DCGI; and (b) to institute a mechanism that will prevent recurrence of such problem in the future."
The joint memorandum explained that after 1988, the SLAs were required to obtain NOCs from the DCGI before granting manufacturing licenses for new FDCs. However, the SLAs ignored the above condition and continued to grant the requisite manufacturing licenses. The office of the DCGI was fully aware of the above practise. In fact, several SLAs had repeatedly brought this practice to the attention of the successive DCGIs, but they had all ignored the practise and did not enforce the new rule.
The rule and practice being divergent, the SLAs granted manufacturing licenses for 294 FDCs since 1988, which is currently estimated at over 10 per cent of the total pharmaceutical market, having sales of approx. Rs 3,500 crore. "If the production of all 294 FDCs were suspended overnight by an order of your department, the market will face sudden shortages of many essential commonly prescribed medicines and patients will face severe hardships," the memorandum added.