In what could be landmark decision for the Union government's with creation of the Central Drugs Authority of India (CDAI) on lines of US FDA, the pharma industry in the country has turned around to vehemently criticize it. This is mainly because centralization of the drug approvals would only lead to more confusion and delays.
The government is making a mockery of itself with the setting up of CDAI. It is nothing but more bureaucracy and red tapeism, which will affect the pharma industry. The CDAI will centralize all operations and withdraw the powers of the State drug licensing authority. This will make all approvals more time consuming and confusing. It will make it more expensive for pharma companies across the country to make additional trips to CDAI, New Delhi and oversee the status of the application for manufacturing licenses, product launches, changes in monograph or new packaging, stated the industry officials.
According to N Jatish Seth, secretary, Karnataka Drugs and Pharmaceuticals Manufacturers Association (KDPMA) and director, Srushti Pharmaceuticals the CDA will now delay the approvals unless proper systems are in place. Even the pharma policy is unlikely to be taking off because there are serious issues pertaining to price control and it will only cause additional burden on the industry.
The Drugs Controller General of India (DCGI) office is already facing a serious manpower crunch and it would therefore not be practical for them to handle all the operation of the pharma industry in the country. Unless decentralization takes place, there will no longer be any professionalism in the approach in the CDA, opined Jatish Seth..
Sunil N Mundra, managing director, Natural Capsules said that centralization of drug licensing by CDAI is going to be a serious hindrance to the growth of the pharma industry. It will slow down the process of meeting deadlines and in the international market this is a negative point. Therefore CDA is now looked upon as an impediment to progress.
Giving an example of the Natural Capsule experience for the mandatory GMP license renewal inspection, Mundra said that his plant has been waiting for license renewal for the last six months and it is still carried out only because the Regional inspector of DCGI office at Chennai has not been able to visit the plant for want of time. The problems are that one man has to handle the entire south India pharma approvals. Shortfall in personnel will make to worse and is expected to definitely postpone several such important issues if CDAI operations are centralized, he added.
Although the CDA was set-up to avoid duplication of drug names and centralize all licenses, it will only complicate the situation of approvals for the pharma sector, stated a section of small pharma enterprises who are already bogged down by the excise free zones which have led to loss of job works.
There is no reality in the setting up a CDA as it will lead to only poor coordination. So far, the companies could approach the state drug licensing authority for certain approvals and now it will not be possible, informed the small unit owners.
While the industry disapproves the formation of the CDAI, pharma consultants in the country said that the creation of CDI is a positive move by the government. "So long the Union government only had a kaleidoscopic view of the drug manufacturers now they will have a clear and direct picture of the production activities which they can co-relate it directly to the patients benefits. It could be possible that the government could relax the strictures in approving production units in different states. It will also be useful if the Union government can take an initiative and force the state governments, which are extremely weak in encouraging the pharma industry. Currently, the pharma industry is concentrated in certain regions as far as manufacturing and marketing activity are concerned.."
With CDAI instituted as an independent body on drugs and coming under the purview of the Ministry of Health and Family Welfare, at the Food and Drug Bhavan, there is also a possibility that the overall healthcare standards can go up with the government taking control on the issuing of licenses for corporate hospitals and other healthcare providers to come up, they added.