The slow progress in officially finalising a solution to the FDC issue is providing an uneven playing field to the drug manufacturers in the country, benefiting a section of companies. While the drug companies which have received licenses relatively recently continue to manufacture these contentious drugs after the Madras High Court stay, others whose licenses have expired are not getting the licenses renewed from the state drug authorities as they are still following former DCGI Dr Venkateshwarlu's directive to withdraw licenses to these combination drugs.
According to industry sources, some companies who still have valid licenses are benefiting from the inordinate delay on the FDC issue as they continue to manufacture these medicines, while the companies whose licences have expired are not getting the licenses renewed from the state drug authorities in the absence of any new directive from the new DCGI.
Sources said the drug companies in the non-excise free zones in the country are the most hit by the indecision on the issue as most of their licenses have either expired or are on the verge of expiry. On the other hand, most of the drug companies who had moved to the excise free zones like Baddi in Himachal Pradesh and Uttarakhand in the year 2005 and after continue to manufacture these drugs as their licenses are comparatively new. The manufacturing licenses are valid for five years.
Even though a consensus was reached in the case of 138 combination drugs in the DCGI-Industry on July 14, the state drug controllers are still not renewing these drugs as the DCGI has so far did not issue any new official communique in this regard.
The companies whose licences have recently expired were pinning hopes on the DCGI-Industry meeting held on July 14 this year. But the delay in issuing formal minutes of the meeting to the authorities has put paid to their hopes as without a new directive from the DCGI the state licensing authorities (SLAs) are not renewing the licences of these contentious combination drugs.
Sources said that the slow progress in the FDC issue is affecting the small pharma units the most as they are lacking the wherewithal to get the licenses renewed from DCGI office in Delhi for each product.