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‘India’s drug regulator can’t be in isolation’

Drugs Controller General of India Surinder Singh speaks to K G Narendranath on the ongoing efforts to harmonise India’s drug regulatory systems with that of the West

INDIA’S drug regulatory landscape has changed a lot in the last four-five years, thanks to a clutch of legislative changes and new rules and regulations — new good manufacturing practices through amendments to the Schedule M of Drugs & Cosmetics Act, registration norms for imported drugs, amendments to the Schedule Y that lays down the protocols of regulatory assessments and approvals for manufacturing/import of ‘new drugs’ and clinical trials, and new norms for medical devices, to name a few. But the regulatory machinery and systems have yet to be in sync with these new laws for their meticulous enforcement and effective delivery of regulatory services. Your comments.
Taking cue from a World Health Organization (WHO) initiative, we have firmed up a plan with Health Canada, the national regulatory authority in that country, to strengthen our key regulatory functions and harmonise the evaluation systems with the developed world. What is on the anvil is a tripartite agreement among WHO, Health Canada and India’s Central Drug Standard Control Organisation (CDSCO) to implement an institutional development plan for CDSCO as per a road map. Last month, joint secretary (health) and myself visited Otawa to give final shape to a training programme in the area of licensing for our regulatory personnel. Earlier last month, a Health Canada mission visited India and stressed on the need to re-organise India’s national biologicals department. A new system for evaluation of biological products such as blood and blood products, sera (which are crucial from a regulatory perspective) will be operational by September.
    Broadly, the objectives of the Health Canada plan is to evaluate and improve upon the independence of regulatory authorities, recall systems, adequacy of staff, dossier review and the system for providing feedback on adverse effects of immunisation from central and state levels. Two expert committees will be set up to provide technical expertise in areas of vaccine licensing (India is a major vaccine producer, accounting for up to 60% of the global supplies of many important vaccines) and oversight of clinical trials. Devising common technical documents (CTDs) for filing of various dossiers will be one component of the programme assisted by the Health Canada. CTDs will be in conformity with the International Conference on Harmonisation (ICH) norms.
    ICH-compliant dossiers will ensure that Indian drug companies find it easier to get regulatory nods from Western regulators like US-FDA once the dossiers are reviewed and approved by the Indian regulator. This would come as a timely help for India’s generic drug companies in their efforts to step up export sales. Also, once CTD system is established, as the national regulator for India we will be more equipped to expediently evaluate new drug applications filed here on behalf of foreign companies. An advanced computerised system for evaluation of dossiers will be set up by September this year. The idea is to move towards e-governance so that the reviews would be transparent and the applicants can even check the status of their filings on-line.
    By the way, we are in the process of shifting from our Nirman Bhawan premises to a newly built, state-of-the-art facility called Foods and Drugs Bhawan.
The central drug regulator is still poorly equipped in terms of manpower and technical expertise. You rely heavily on state government machinery for enforcement.
We’re adding to our human resources. Twenty new central drug inspectors, 48 additional technical experts and many more as supporting staff. It is true that this will not suffice. To a certain extent, we will have to depend on the state government machinery.
What about the plan to have a Central Drug Authority (CDA) as the sole licensing authority for drugs?
The CDA Bill has been introduced in the Rajya Sabha and so, it won’t lapse. The Bill is being examined by a Parliamentary standing committee headed by Amar Singh. Since the proposals in the Bill — like divesting the states of the power to grant drug licences— will have wide-ranging ramifications, it is natural that deliberations are not rapped up quickly. (Currently, the Centre— DCGI— is the approving authority for all ‘new drugs’ as defined in the Drugs & Cosmetics Act, vaccines, blood and blood products and large volume parenterals. This means that the states can issue licences only after getting the DCGI’s assent. For other products, the states can issue licences on its own. However, many states used to unilaterally issue licences for the products that need the Centre’s approval as well and the CDA Bill proposes to scrap the licensing powers of states once and for all).
    There are certain practical questions pertaining to the proposal to centralise drug licensing, like the concern over the likely hassle of drug manufacturers needing to come to Delhi for each licence and its renewal. We propose to address these concerns by authorising zonal and sub-zonal offices of the central authority (there are six such in total) to renew licences.
What will be the structure of CDA?
The authority will have a chairman at the rank of secretary to government of India and three to five members, assisted by the DCGI. There will be 10 divisions— regulatory affairs & enforcement, import, new drugs and clinical trials, biologicals and biotechnology products, pharmacovigilance, medical devises and diagnostics, organisational services, training & services, quality control affairs and legal & consumer affairs.
Will the Drugs Technical Advisory Board (DTAB), the statutory body of experts, continue to exist?
No, CDA will replace the DTAB. The Drugs Consultative Committee of state drug controllers will be re-organised by including few experts as members.
At present, India does not permit Phase I clinical trials (first time administration in humans) of new (potential) drug molecules discovered in a foreign country, unless the same trials are already done in a foreign country and results are known. This is said to be hampering the country’s efforts to partake in global drug R&D. Any rethink on this policy?
We are reviewing this policy. The rationale behind the move is that we need to give fast-track approvals for drugs that are relevant to Indian population. Even now, we are allowing Phase I clinical trials without foreign results in case of molecules of Indian origin. Molecules derived from R&D done abroad can be treated on a par if it is presupposed that the potential drug would be significant in the Indian context. The Schedule Y needs to be amended to make this policy change. We plan to do this shortly.
A recent statement by you of a plan to disallow marketing pleas of generic versions if a patent is already issued evoked mixed reactions. Won’t such a policy amount to crippling India’s generic industry?
What we are contemplating is to pursue the middle course. If we totally ignore (the pleas for patent linkage from originator pharma companies), the country’s reputation is at stake. India is reckoned to be major force in the global arena in pharmaceuticals, as in many other fields. So, we cannot be in isolation. But we cannot be as strict (on ensuring patent linkage) as some countries in the West, because our strength lies in generics. We will work out a system only after broadbased consultations with all stakeholders.
How serious is the oft-reported issue of spurious drugs?
A recent (June 2007) study of 10,000 random samples by an agency showed that only 3.1% of these samples can even be “suspected to be counterfeit,” and lab tests of these suspected samples verified that just 0.3% of the total 10,000 samples can be said to be sub-standard (not having the active pharmaceutical ingredient in required quantity). So, many reports are overstatements. But that doesn’t mean that we are lax on curbing the menace of fake drugs.

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