The Drug Controller General of India is upset over the recent charges leveled by the industry on the functioning of Central Drugs Standards Control Organisation (CDSCO). He was of the view that the industry should not overlook at the quantum of work the CDCSO has been delivering despite a poor infrastructure and inadequate personnel strength.

Responding to the industry allegations, which was flashed on www.pharmabiz.com on July 20, Ashwini Kumar, the DCGI said that the complaints are mainly raised by the manufacturers with incomplete applications or who do not have compliance on various regulatory norms.

It may be recalled that the pharma industry in India have been complaining about the chronic procedural delays at the CDSCO when the manufacturers approaching the department for various regulatory clearances. The industry sources even alleged that such delays by the offices of the department are putting pharmaceutical companies in a serious dilemma of late and the slow pace of working by the officers are even crippling domestic industry's chances to turn global.

The industry had complained that many drug companies are facing the prospects of losing foreign contracts in formulation and intermediate exports as well as bio-equivalance and clinical trial contracts due to the absence of timely regulatory clearances.

Pharmabiz had reported that pharmaceutical companies have complained that the performance of the CDSCO is dismal and has no systematic approach in processing and disposing off various applications received for regulatory approvals involving new drug approvals and export related issues. There is unanimity in their demand for a totally revamped drug regulatory directorate where powers are properly delegated to technical officers who are competent enough to give timely clearances.

Ashwini Kumar pointed out that such kind of allegations will only help in tarnishing the image of the country's drug regulatory system amongst the international community. He, however, informed that he is going to write to the industry associations to maintain industry discipline and to be very cautious while putting such comments against competent authorities.

He added that the department is currently in the process of improving its performance by enhancing its infrastructure and personnel strength. The CDSCO has also requested the government to extent necessary helps to overcome the existing bottlenecks, the DCGI added.