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New Delhi, April 12, 2019 :
In my opinion, India needs a single Drug Regulatory System under a federal set-up. This may solve all the drawbacks that plague the present drugs control administrations in both Center and States. It will also eliminate the PAN India presence of Not-of-Standard-Quality (NSQ) drugs, which pose a challenge to regulators all over India.
As a permanent solution to this technical snag, the central and state drugs control administrations (Central Drugs Standard Control Organisation [CDSCO] and state DCAs) should merge into one single entity under the federal set up of the constitution.
Moreover, for effective implementation of the provisions of drugs and cosmetics act (D&C Act) and the Rules there under in a uniform manner, the present parallel system of enforcement is always a hindrance. Due to these dual regulations, the menace of Not of Standard Quality (NSQ) drugs, spurious and adulterated drugs cannot be eliminated from the market. The regulatory departments are unable to ensure quality of the drugs in the Indian market.
If there is a single system under a federal set up, it will help the Indian pharmaceutical and allied industry to grow exponentially and become a global leader within a short span of time.
Today India has a crying need to address the issue of NSQ drugs. As per data collected from 30 states in 2017 India has over 12000 manufacturing units, but has only 1,500 regulatory staffs. This indicates the inadequacy of the drug regulatory system of our country.
The present scenario of Indian regulatory system is a parallel type of a set-up wherein the CDSCO and the state drugs control administrations (state DCAs) function parallel to each other with obvious inherent disadvantages and demerits. The important issue to be tackled is non-uniformity in the implementation of the D&C Act and the Rules.
India lacks a single monitoring system and the biggest lacunae in the system of regulation are lack of infrastructure and manpower. This shortage has brought down the efficiency of the central and state regulatory agencies for implementing the drug laws. The primary responsibility of the enforcement agency is to ensure availability of standard quality drugs to the public, but as long as these two agencies function separately, the discrepancies that affect the system now will continue to exist.
There were instances of irrational drug combinations and FDCs, not approved by DCGI, flooded the Indian market due to grant of permissions by the state licensing authorities.
Guidelines issued by Drug Controller General of India (DCGI) with respect to dealing with NSQ drugs are not uniformly implemented across the country. This is a matter of great concern. For grant and renewal of licenses for blood banks take years due to lack of coordination between the officers of the central and state departments, shortage of inspection staff as well as supporting staffs.
Therefore, to conclude, I would suggest the Chamber should start advocating for a Federal Agency for the entire nation who can also then implement the act uniformly without leaving any loophole for corruption or violation or offence.
Regarding drug laws, there should not be the provincial regulation, but there should be a federal regulation.
The author of this artlcle is Dr KK Aggarwal, Padma Shri Awardee
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