India’s Drug Regulatory Reforms: Building Trust


Dilip Shah, the Secretary-General of the Indian Pharmaceutical Alliance advocates for a stronger and more empowered regulator in India if the country is to build public confidence in its pharma output and drug inspectors. 


Improving the image of drug inspectors- will require investments in “infrastructure”. The key elements of this “infrastructure”, besides more labs and manpower, are culture, capability and integrity. 


On 21 December 2018, in his inaugural speech at the 70th Indian Pharmaceutical CongressDr S Eswara Reddy, Drugs Controller General of India (DCGI), the country’s top regulator agency, outlined his priorities for the next five years: building trust and confidence in the quality of the medicines that are manufactured, imported and sold in India, and building a positive image of drug inspectors. 


These are laudable goals but they will require “political will” and supportive “infrastructure”.


Improving Quality 


With regards to quality, political will is necessary to enforce stricter compliance. So far, the political leadership has always opted for a soft approach with a tendency to protect the units which will have to bear the brunt of compliance audits: Micro, Small and Medium Enterprises which provide maximum employment in India. There, authorities will have to make a choice. 


While there is still a long way to go to establish the uniform quality of all generics in the country, it would be cynical, however, not to acknowledge that there have already been significant initiatives to improve it. Here are a few of them:


BCS System for New Drug Approvals:

The first step to improve quality was taken in April 2017. The Ministry of Health & Family Welfare (MoH&FW) then notified that all applicants of new drugs shall submit the result of bioequivalence study for oral dosage forms of Category II and Category IV drugs of the Biopharmaceutical Classification System (BCS)2. However, the need for bioequivalence of the existing oral dosage forms has not yet been addressed.


Ban on Fixed-Dose Combinations (FDCs):

The MoH&FW set up an expert committee in 2014 to examine 6,220 fixed-dose combinations (FDCs) with the objective of banning irrational combinations.  An FDC is a combination of two or more active ingredients in fixed dosage. Many of them were approved by the State Drug Authorities without the knowledge of India’s Central Drug Regulator (CDSCO).  Some of these FDCs were marketed for over 30 years. The foreign multinational companies, large domestic companies, many medium and small companies, totalling over 1,000 firms, were promoting these FDCs. After the expert committee identified 400 odd FDCs as irrational, every attempt to ban them was frustrated by the industry. In 2018 The Drug Regulator finally succeeded in banning over 400 FDCs, thereby protecting patients from irrational use of medications.



With Frost & Sullivan estimating that online sale of medicines could account for 15%-20% of total pharma sales in the next 10 years from the current share of about 3% in 2018, ePharmacy is bound to become an important element of the new drug regulatory regime. To that end, the MoH&FW already announced a Draft Rules for ePharmacy3 in August 2018.  This opens up an organised channel that could help ensure quality.  


Simplification and Ease of Doing Business:

The Drug Regulator has adopted a “carrot and stick” approach to improve Quality.  Just as it pushed for measures such as BCS for new drug approvals and banning irrational combinations, it offered sops to soften the opposition to reforms.  These sops included simplification of processes involving bureaucratic delays and harassments.  To this endthe tenure of licenses (permissions) has been raised, unless suspended or cancelled by the licensing authority.  Several forms have been done away with or merged. In a significant decision, the CDSCO has agreed to enforce all modifications to labelling requirements from the first day of the financial year, i.e. 1 April5.  This would allow transition time and gradual phase-out of inventory, eliminating the national waste of packaging materials.


Building a Positive Image


Achieving the second goal – improving the image of drug inspectors- will require investments in “infrastructure”. The key elements of this “infrastructure”, besides more labs and manpower, are culture, capability and integrity.  Whilst building up the physical infrastructure and addition to manpower could be achieved in a couple of years, the cultural and behavioural changes will take much longer.  Building a positive image of drug inspectors requires a focus on culture, capability and integrity of drug inspectors.  


In this context, it is pertinent to take note of a unique experiment undertaken by the IPA in conjunction with the USFDA and India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO) — the IPA Quality Forum which embarked on a journey “Towards Quality Excellence.” 


It roped in other global regulators such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medical Agency.  Together they designed capability building events with input from all regulators and industry: Advanced GMP Workshops from 2015 and the Indian Pharmaceutical Forum from 2016.  


The Workshops have so far exposed about 700 middle management personnel from the industry dealing with quality, manufacturing and regulatory matters and about 200 local drug inspectors (funded by the IPA) to the global regulatory standards.  


The Forum has so far exposed 700 senior management personnel from the industry and 100 CDSCO officers (funded by the IPA) to the sustainable quality culture and effective quality management system. This is unique because the IPA has taken upon itself to work towards strengthening the regulatory infrastructure.


There are islands of excellence in the system, but there is much room for improvement. The MoH&FW may have to rely on the public pressure and industry support to push these efforts.


The actions initiated by the MoH&FW and the CDSCO are commendable and indicative of direction, but not enough to transform the regulatory regime.  A lot more needs to be done. The foremost among them is modifying the ineffective federal structure, empowering the Drug Regulator, elevating the position of the Drug Regulator, participating in global forums and resisting ad-hoc decision making.

Related Content

Latest Report