In order to remove regulatory discrepancies in implementing the Drugs and Cosmetics Act, 1940, the Centre’s health advisory body Drug Technical Advisory Board (DTAB) has recommended several measures to the Union health ministry. Currently, India has 37 drug regulators — one central drug regulator known as the Central Drugs Standard Control Organization (CDSCO) and the remaining 36 are drug regulators of various states and Union territories. These regulators have been implementing the Act, which regulates the drug sector, as per their own understanding, thereby leading to discrepancies.
Recommendations given by the DTAB on June 16 to the ministry include cadre restructuring, ensuring adequate staff for drug regulation at the state level, deputing state officials at the Centre and vice versa, deputing just one official in each state as the licensing authority (LA), informing state government instead of state drug controller about each new rule or guideline of the Central government and preparing new guidelines for disposal of expired drugs.
“The central government should issue direction to the state governments to ensure adequate regulatory officials which will commensurate with the number of sale outlets and manufacturing units located in the respective states considering that there would be one official for every 200 sale outlets and one official for every 50 manufacturing units,” the DTAB stated in one of its recommendation.
Another recommendation was that each medical device officer should at least have a Bachelor of Pharmacy (B.Pharma). The board stated that each such officer should undergo training in medical device regulation under a training module that is being developed in joint collaboration between Delhi Pharmaceutical Science and Research University and the Indian Pharmacopoeia Commission.
Ashish Prasad, partner, Economic Laws Practice, told The Indian Express: “The recommendations are a good step forward and will help in more uniform and effective implementation of the Act and Rules. To be really effective, the intent must be followed up with periodic regular training and monitoring of activities of state-level regulatory officers… Drug regulatory policies, even if they relate to those matters over which the Central Licensing Authority only has powers, must be clearly communicated to state-level officers to encourage a holistic understanding of the implementation of the Act.”
The DTAB suggested the health ministry that each state’s drug-controlling authority should create an intelligence cell with a nodal officer for market surveillance and conducting investigation related to spurious or adulterated drugs. Such investigation should be conducted in coordination with the CDSCO, as per the DTAB. Moreover, the board stated that “drug samples from supply chain of (the government) procurement agencies need focused monitoring for ensuring quality of drugs”.
“It’s a matter of concern that a high percentage of drugs in the government supply chain are found to be sub-standard. More focused monitoring of samples of drugs from supply chain of procurement agencies will ensure effective enforcement of the Act and Rules,” Prasad stated. However, he added that in order to make any such monitoring recommendation effective, it would need to be “coupled with observance of necessary rules” related to storing and testing the drug sample.
The board has also recommended that the government procurement agencies should be permitted to get their drug samples tested at “approved” private laboratories and obtain test reports in Form 39 (This form is generally used by such drug laboratories to issue reports for pharmaceutical companies that do not have testing facilities.). The DTAB added that the Drugs and Cosmetics Rules, 1945, need to be amended to prescribe a separate form so that private laboratories can issue such reports to government procurement agencies.