India needs a three-pronged strategy to ensure regulatory accountability

Bengaluru, October 28, 2022 :

India needs a three-pronged strategy to ensure regulatory accountability. First is the centralization of the drugs control departments across the country. There is a need to create a cadre on similar lines of IAS (Indian Administrative Service), IPS (Indian Police Service) and IFS (Indian Forest Service) where the selection of officers is through UPSC (Union Public Service Commission).

Second is that the CDSCO should immediately have an Intelligence wing or branch with upright officers that function on similar lines as that of the CBI (Central Bureau of Investigation). Similarly, each state should have their own State Intelligence Branch which needs officers to uncover crime and unscrupulous activities besides spring into action for investigations. Third is that all regulatory actions need to be taken up in a time-bound manner with no delay whatsoever, said Dr. BR Jagashetty, former National Adviser (Drugs Control) to Union health ministry and CDSCO and former Karnataka State Drugs Controller.

These three things have to be done immediately. Our country needs a strong regulatory body. All regulatory activities need adhere to TAP which is Transparency, Accountability and Punctuality. All inspections and their outcomes need to be carried out within a stipulated time-frame with transparency. Only such action will ensure that the Indian regulatory authority is credible, he pointed out.

Close on the heels of the Gambia tragedy of paediatric fatalities wherein 66 children succumbed to prescribed cough syrups manufactured by the Haryana-based Maiden Pharmaceuticals, is an incident that has marred India’s image as the pharmacy of the world, Dr Jagashetty noted.

Therefore, there is a need for strong regulatory, GMP compliant industry and pharmacy trade to be accountable and be able to trace and track the source to protect the reputation of the country, he said.
 
Although, the government is in the process of implementing the trace and track for 300 fast moving brands in the form of bar code or QR Code for which a draft gazette notification has been issued creating a separate schedule H2, yet there have been a delays in investigations when spurious and contaminated charges have been reported. We also need track and trace guidelines to be announced & implemented for the domestic market too, he noted.

Only centralization of the drugs control departments in the country retaining the existing powers of State officers like that of licensing, cancellation/suspension, prosecution etc., will enable a clear chain of directions, allow standardized procedures and better supervision of medicines manufactured and distributed pan-India, he said.

Therefore, there is an imminent need to a create cadre on par with IAS, IPS and IFS through UPSC. Our CDSCO should be renamed as the Indian Medicine Regulatory Service and should be made an autonomous body. Accordingly, the status of DCGI has to be enhanced & should function independent. Officers of the rank of above deputy drugs controllers should be liable for transfer across the country to have the exposure to the developments in the states and proper enforcement, he pointed out.

The suggested Indian Medicine Regulatory Service should include under its umbrella the departments covering the quality aspects of any type of drugs, medical devices, cosmetics, supplements among others. The officers can work in various departments wherever the quality, procurement etc of medicines including monitor the collection of medicinal herbs and plants etc., medical devices, cosmetics. Such a move is envisaged only to bring in better control and accountability, said Dr Jagashetty.Pharmabiz