Health ministry is planning to recruit 1045 drug regulators at Central Drugs Standards Control Organisation (CDSCO) besides strengthening drug testing infrastructure, expanding the reach of pharmacovigilance programme at the grassroot level, implementing e-governance and setting up of a training academy for drug control staff in the country.
A report of the working group on drugs under the 12th Five Year Plan has been submitted to the Planning Commission for sanctioning of Rs. 630 crore for upgradation of manpower at CDSCO, Indian Pharmacopoeia Commission (IPC) and the National Institute of Biologicals (NIB), Rs. 360 crore for additional manpower at 8 new drug testing labs, Rs. 135 crore for manpower at existing 6 testing labs and Rs. 100 crore for Pharmacovigilance Programme. The plan will also envisage setting up of 20 mini labs, pharma research lab, cosmetic lab, diagnostic kit lab, medical device lab and a CDSCO training academy for drug regulators.
The plan was discussed with a delegation of pharmacists represented by Udyog Development Foundation (UDF), a not for profit organisation which recently concluded the Indian Pharmacists Revolution (IPR) Yatra from Kashmir to Kanyakumari in its recently concluded meeting with A K Panda, joint secretary, drugs, ministry of health and Shailendra Kumar, director, drugs, ministry of health. "In order to bring about uniform policy for pharmacy professional, we have also recommended setting up a separate directorate of pharmacy to implement standards in the cadre, salary structure and promotion avenue of pharmacists," informs Amitav J Choudhury, chief coordinator, UDF.
As per the recommendations of the report, the Central Government should also construct new CDSCO offices at Ahmedabad, Jammu, Bengaluru, Indore, Goa, Guwahati and New Delhi. The approximate financial outlay for these offices would be Rs. 35 crore. Rs. 60 crore is required for upgradation of existing CDSCO offices. Rs. 96 crore for creation of mini labs at Ports (both at Sea and Air ports where drugs are imported/exported). The Central Government should create new Central Drugs Testing Laboratories to strengthen testing capacity. It is proposed that having regard to expanding pharma industry in the country the Central Government should set up 8 new laboratories at the cost of Rs. 40 crore each amounting to total Rs. 320 crore. The Central Government should upgrade existing CDSCO’s 6 labs at the cost of Rs. 15 crore each. The financial outlay is Rs. 90 crore.
There is a need to establish CDSCO training academy for updating knowledge and skills of the regulatory officials. The approximate cost for creating of CDSCO training academy would be Rs. 50 crore. Effective management of the issues on spurious drugs lies with the drug regulatory agencies at the Centre and in the States. The menace of spurious drugs would be checked by providing mobile drug testing laboratories. The cost of each mobile drugs testing lab would be Rs. 5 crore and there is a need of 20 such laboratories all over India entailing a cost of Rs. 100 crore.
Although many Central Drugs Laboratories have adequate facilities for testing of drugs (quality) as per the prescribed standards, these laboratories are not well equipped to test foreign (contaminated) substance in drugs. Hence there should be a State of the Art Pharma Research Laboratory to carry out sophisticated analysis of drugs to detect such substances. For the setting up of such laboratory, the financial outlay would be Rs. 50 crore.
The sub group which drafted the report is of the opinion that problems in the drug regulatory system in the country are mainly in the following areas like inadequate manpower at the State and Central level, inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, non uniformity of enforcement of law and regulation, lack of training to regulatory officials, lack of data base and inadequate IT services. These problems have got further accentuated with the increasing growth of the pharma industry in the country.