Pharmaceutical companies in the country may have to cope with serious delays in getting their applications for drug licenses cleared once Central Drugs Authority (CDA) of India is formed. Such delays in the initial phase of its existence are inevitable as the staff strength of Central Drugs Control Organisation is highly inadequate to handle the vast number of applications that may pour in from various states, according to All India Drug Control Officers Association (AIDCOC).
The Central Drugs Standard Control Organisation (CDSCO), which is to be entrusted as the licensing authority for drug formulations under the CDA, has staff strength of less than 40 now, whereas the current strength of drug control officials in states is around 1,200. Although there are recommendations to induct more staff into CDA, the chances are less for the time being as such large scale recruitment of staff will take time, officials said.
"The staff strength of CDSCO is over 75 per cent less than the existing staff strength of state drug control officials all over India. This limited number of staff has to issue licenses for several thousands of products in the entire country. We doubt whether with the existing infrastructure, the authority can meet the challenge of issuing licenses for these products without delay," Ravi Uday Bhaskar, Secretary General, AIDCOC told Pharmabiz.
As the authority has not come up with any specific details on increasing the staff strength, adding more infrastructures is not practical. There has been no major recruitment of staff in CDSCO for the last 7 to 8 years despite assurances in this regard by the central government, he added. On the other hand, the state drug control authorities are increasing their staff strength and yet many of them are not able to operate efficiently, maintained Uday Bhaskar.
The new responsibility of issuing product licenses may lead to the collapse the entire operations of the CDSCO, as the existing limited number of officials have to carry out the multiple tasks including inspection and licensing of blood banks and evaluation, screening and granting of NOCs for export of unapproved or banned drugs, Bhaskar pointed out. He revealed that the present number of zonal offices under CDSCO, is inadequate to carry even the current procedures under their purview.
One of the main attractions for CDA is said to be the introduction of a common database of approved combinations all over the country. Currently there is no comprehensive database, which leads to improper approvals by various state drug authorities. If a database is provided to each state drug authorities, the current system itself can give more accurate results, he opined.
A database of the approved combinations and merging of the current state drug control infrastructure under the CDA would be a better option than setting up a completely new infrastructure for licensing. "The government should move towards such practical decisions instead of coming out with fancy proposals which may collapse the existing facilities," added Uday Bhaskar.