CDSCO’s planned ‘harmonisation of recruitment rules’ is sure to resurrect this debate
In his message for 2015, Dr GN Singh, Drug Controller General (India) (DCG(I)), pledges that this year would be for ‘streamlining of regulatory procedures without compromising patient safety’. A laudable goal and it dovetails with CDSCO’s statement on policy initiatives planned for 2015.
Many of these initiatives are in continuation from the past year, but the initiative sure to generate a lot of debate is the ‘harmonisation of recruitment rules’ for the post of DCG(I) and certain other posts in the CDSCO as well as in the Central Drug Testing Laboratories.
Sources reveal that an expert committee, chaired by Satyanand Mishra, former Secretary, Department of Personnel & Training (DoPT) and former Central Information Commissioner, has been appointed by the Ministry of Health & Family Welfare (MoH&FW) to examine/ review the recruitment rules for these top drug regulatory posts.
Industry observers see an attempt to (once again) revise recruitment criteria, from the current mandatory pharmacy qualifications and experience to medical qualifications. Is this a turf war or something beyond?
Many in the pharma industry cannot see the logic in this move. The reasoning is, why fix it if it ain’t broke? The Delhi Pharmaceutical Trust is one such group, consisting of professional pharmacy experts. In a letter to the MoH&FW dated November 20, 2014, the Trust has supported their argument by pointing out that the appointment of a surgeon as drug controller is fraught with as much risk as making a doctor the chief of army, under the belief that after all the army involves the health of serving and wounded soldiers.
An acknowledgement receipt dated December 22 was delivered to the Trust on January 4, leading them to conclude that the matter is “under active consideration.” If this is true, then the debate on the recruitment rules for the most crucial posts in the country’s pharma regulatory mechanism will be opened once again.
The Trust’s main rationale is that drug regulation in India involves regulation of the manufacture of quality medicines and not managing healthcare programmes. The latter would call for the healthcare delivery skills of a medical practitioner as it requires in depth understanding of disease diagnosis and treatment. Thus India cannot be compared to other countries where it may be appropriate to have medically qualified personnel heading their drug regulatory systems.
The Trust is right when it points out that pharmaceutical sciences and medical practice have evolved into completely different and mutually exclusive specialisations, even though they are both part of the overall healthcare system. The letter points out that each of the two streams have different subjects taught and rightly each have a separate regulatory mechanism. Industry sources mention that we do have one example of a medico who served as DCG(I): Dr P Dasgupta but maintain that medicos should not serve as drug regulators.
Is this development a sign that the Ministry believes that something in India’s drug regulatory system is indeed ‘broke’ and needs fixing? How is it that in the past two years, many global regulators have imposed import alerts and product bans, a reflection of less than adequate manufacturing practices of pharma companies in India, while the same facilities clear the CDSCO’s inspections? This reasoning may be flawed on many levels but maybe the Ministry is under pressure to be seen to be fixing it.
All change is painful and the industry would do well to adopt a collaborative rather than a confrontational stance. Some of CDSCO’s planned policy initiatives like the ‘introduction of provisions relating to phytopharmaceutical drugs under the system of modern medicine’ are welcome because they seem to indicate that India is following in the footsteps of global regulators like the US FDA and Health Canada which already have separate norms for botanical-based medicinal products rather than clubbing them under the rules for chemical-based drugs.
The review of the Drugs and Magic Remedies (Objectional advertisement) Act, 1954 is also a welcome idea, given that much has changed since its inception six decades back. There is increasing evidence of violations of the fine line between information and advertisement, which directly impacts the end user/ consumer/ patient.
Other policy initiatives like the simplification and rationalisation of various applications and licenses as well as e-governance and digitisation will also get an enthusiastic thumbs up. Publication of revised National List of Essential Medicines as NLEM, 2015. So will the finalisation of accreditation standards for clinical trials for ethics committees, investigator and clinical trials; the evolving of a Public Private Partnership model for engaging laboratories in private sector and the setting up of training institutes within the existing premises of the National Institute of Biologicals, Noida.
This year is sure to bring many more surprises, not all of them good.