AIDCOC says the proposed joint inspections of pharma manufacturing facilities by drug inspectors of the state and centre will lead to “dual control…delay and undue hardship to licensees”
A recent amendment to the Drugs and Cosmetics Rule 1945, and subsequent notification, has once again revived the turf war between the centre and state level drug inspectors. The notification GSR1337(E) dated October 27, 2017, deals with validity of licenses and provision for joint inspections of pharma manufacturing facilities by drug inspectors of the state and the centre prior to issuing licenses.
In a letter dated November 14, to the Health Minister, M Dhilip Kumar, President, All India Drugs Control Officers’ Confederation (AIDCOC) says the amendment will lead to “dual control which will lead to delay and undue hardship to the licensee and will also adversely affect the state government’s ability to provide services with the desired speed and within specified time limit.” The letter has requested the health minister to keep the amendment in abeyance till a final decision is taken.
While the division of responsibilities between the Central and state governments require legal opinion, logistics suggest that the present staff strength and geographical footprint of the central drug authority do not match up to that of the state drug control machinery.
According to the AIDCOC letter, state drug departments have approximately 3,000 experienced staff to monitor the manufacturing licenses of the approximately 10,000 pharma units in the country. In contrast, the total sanctioned strength of inspectors under central government is reportedly 271, of which 147 are recently recruited and therefore not trained. Thus only 124 trained drug inspectors attached to the central government are available for proposed joint inspections.
To make matters worse, these joint inspections will be in addition to their current duties related to the Central Licence Approving Authority (CLAA) and joint inspections in WHO-GMP, Certificate of Pharmaceutical Products (COPP), EU-WC etc. The implication is that joint inspections could disrupt the normal duties of centrally attached drug inspectors.
In terms of geographical spread, the letter points out that the CDSCO does not have offices in some states like Andhra Pradesh, Odisha etc so manufacturers in these states would find their offices inaccessible. In contrast, state drug officers/inspectors are present at sub-divisional level, supervised at the district and regional levels, and are hence able to inspect, monitor and issues approvals and licenses within the time frame.
The current system of the CDSCO at the centre focussing on policy issues, leaving the state resources to focus on implementation, has served India’s pharma sector very well. It has grown into a $36 billion industry, more than 50 per cent of this being exports to highly regulated markets. The Pharmacy of the World is dependent on numerous manufacturers across the country, and these in turn, need an accessible and streamlined regulatory mechanism. While the sector looks to the CDSCO to focus on quality, exports/imports and policies, the state machinery is best positioned towards licensing and inspections.
If Prime Minister Modi’s Ease of Doing Business (EoDB) initiative is about decentralising decision making and devolving responsibilities to the relevant stakeholders, then the proposal for joint inspections seems like a step backwards. Instead of empowering the state level inspectors with more authority, it seems to be adopting a ‘Big Brother’ approach. Joint inspections cannot be seen as a hand holding and resource building exercise, say sources, as it will weaken rather than strengthen their roles.
To be fair, the proposal for joint inspections is still a work-in-progress. The Drug Controller General (India) (DCGI) followed up with a letter dated November 24 to all state/union territory drug controllers, which mentioned that detailed guidelines would be prepared in consultation with the state drug controllers and other stakeholders “for effective and uniform implementation of the joint inspection of manufacturing premises.”
Given that their previous representation went unheeded, AIDCOC has decided to take things to the next level. State drugs controllers met on December 16 and planned future strategy. AIDCOC has since filed a writ petition in the Chennai High Court asking that the amendment be declared as ‘ultra vires, unconstitutional, arbitrary and illegal.’ We have clearly not heard the last on this issue.
There does seem to be a genuine move to increase EoDB in the pharma sector. At the recently held 14th National Pharmaceutical Conclave 2017, Dr GN Singh, DCG(I) said his office is working towards making the regulatory framework seamless in the next six months. A CII-KPMG report on ‘Ease of Doing Business in the Pharma Sector’ released at the event presented recommendations from industry related to the marketing authorisation process, clinical trials and manufacturing approvals. But such recommendations will remain on paper, if all stakeholders do not resolve conflicts, define a common goal and then work towards it.