The stalemate over the issuing of product license and the renewal of licences for the existing products continues with the state licensing authorities (SLAs) not getting any specific directive from the DCGI office in this regard. During the last about six months, the state drug authorities in Maharashtra did not issue a single licence for the fixed dose combination (FDC) drugs.
In the wake of Madras high court stay order granted to CIPI in November last year on the DCGI order asking the SLAs to withdraw licences issued to FDC drugs, the state drug authorities have been looking upon the DCGI for specific direction. The SLAs had written letters to the DCGI for action in the aftermath of the stay order. But the DCGI did not so far give any specific direction in this regard to the SLAs in writing.
In the absence of specific DCGI directive on the issue, the Maharashtra FDA stopped issuing product licences and all files are finding its way to the DCGI office. During the last about six months, the Maharashtra FDA has received two applications, one each from Emcure of Pune and Jelnova of Mumbai, for license. Since the FDA did not receive either the copy of the Madras high court order or the counter-affidavit filed by the DCGI office, the FDA forwarded both the applications to the DCGI for a decision, a senior FDA official said. Both the companies have applied for FDC drugs which were included in the 294 FDC list.
According to FDA officials, the drug department normally receives an average 20 applications in a day. But, after the DCGI order in June last year to withdraw licenses to the FDC drugs, the manufacturers are being asked to approach DCGI office for product manufacturing licenses.
In fact, the manufacturers have been hopeful of getting license from the state FDA in the aftermath of a series of Madras high court stay orders which stayed the DCGI order. Drug manufacturers associations had written to the SLAs in this regard citing the Madras high court order.
But since there is no specific directive from the DCGI in this connection, the stalemate continues, leaving the SLAs literally in the lurch.