Chronic delays in clearing various regulatory approvals by the offices of Central Drugs Standard Control Organisation are putting pharmaceutical companies in a serious dilemma of late. Such delays caused by slow pace of working by the CDSCO offices are, in fact, crippling domestic industry's chances to turn global.
Industry sources here point out that many drug companies were 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.
The pharmaceutical companies complain that the performance of the CDSCO was dismal and has no systematic approach to processing and disposing off various applications received for regulatory approvals involving new drug approvals, FDC 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.
They feel that the current system, where the Drug Controller General of India is the only designated authority, which can clear the entire regulatory requirements of one of the fastest growing industrial segment in the country, is totally out of place.
"The backlog and pendency rate is very high in the directorate as it is grossly understaffed. One cannot blame the DCGI alone for the delay in clearances. How many signatures a single man can put on a given day?" they ask.
Though there is no clear indication of the exact number of pending applications, industry sources en masse points out to their "un-cleared applications" as proof of their woes.
It is not just the new drugs applications that are known to be held up for months in the directorate. Even the clearances of test licenses (Form 11) are taking several months. Industry sources pointed out that in several cases, even after repeated requests, the office of the DCGI is not in a position to furnish a reply on the exact status of the applications.
The absence of timely clearances of test licence applications is threatening many of the ambitious long terms export strategies of Indian pharmaceutical companies, it is learnt. The companies need to get drugs imported from their potential export markets for several reasons. It could be for developing a similar drug, for comparative studies with the Indian counterparts, for preparing dossiers for foreign regulatory agencies or to work on some products as part of buy back export contracts etc. Drug companies say that an application, which normally should not take more than three weeks to get cleared, is taking, on an average of three months currently.
It should be noted that the Indian pharmaceutical industry is expected to grow from the present $5 billion to $25 billion by the year 2010. To achieve this growth target, the industry needs to step up the export of generic drugs to the regulated markets, besides adding more therapeutic areas for domestic growth. Pharmaceutical companies complain that the directionless and inefficient functioning of CDSCO has become the greatest threat for achieving this target now.
Meanwhile, the CDSCO officials feel that they are doing their best within their limits. "It is a known fact that the department is grossly understaffed. We lack even basic infrastructure. Instead of criticising us, one should try to congratulate us for the work we are doing under such inhuman conditions," they say.
Interestingly, many companies have appointed dedicated liaison officers just to see that their files are pushed to the top from among the bunch of applications. It is alleged that "out of the way" deals are fixed due to this rush for clearances. The seriousness of the issue can be understood when one realizes that even the New Delhi based-Ranbaxy Laboratories, India's largest pharmaceutical Company, had to engage a freelancer to see that their files are cleared on time.
The industry also alleges that the due to the present state of affairs in the directorate, freelancers representing traders dominate and pharma industry's organized industry applications are only given least priority.
On the one hand, Mashelkar Committee had recommended and envisaged a World Class FDA to meet the challenges ahead for the pharmaceutical industry and on the other hand, there is no move to suggest that the time bound suggestions of the committee are heard.
With the new patent regime just five months away, the industry wants the Central Government to understand the urgency of the situation and initiate some interim steps where in the functioning of the directorate can be made systematic, until the World Bank-supported Capacity Building Project in the Foods and Drugs Sector is complete, and the Mashelkar's proposals are implemented.