Central Drug Authority to have sweeping powers
separate divisions to regulate clinical trials, new drugs, etc

KG NARENDRANATH & SURABHI

NEW DELHI, JUNE 27: The proposed Central Drug Authority (CDA) is envisaged to be fully autonomous and financially self-sustaining. It will have separate divisions for regulatory oversight of clinical trials, new drugs, medical devices, cosmetics, vaccines & biologicals, Good Manufacturing Practice-compliance etc., drugs controller general of India, Ashwini Kumar told FE.

The authority would be modelled on the lines of the United States’ Food & Drugs Administration (US-FDA). CDA would be authorised to devise a fee structure for its regulatory services and recruit personnel, the official said, adding, the proceeds from the service charges would be utilised by the CDA to meet its capital spend and day-to-day expenses. CDA would closely interact with the drug watchdogs abroad to harness regulatory expertise.

It would be supported by an advisory board. The executive wing of the regulator would be headed by the Drugs Controller. However, each division overseeing defined activities pertaining to drugs and cosmetics research and commercialisation would be largely independent. Empowering the CDA would require a few amendments to the Drugs & Cosmetics Act.

It may be noted that in a Cabinet note circulated recently, the Union health ministry had proposed setting up of CDA as an agency for centralised drug licensing. The move followed the proposals made by many expert bodies including the Mashelkar Committee which pitched for a comprehensive revamp of the drug regulatory system in the country.

Kumar said centralised drug licensing would help introduce a level-playing field for the pharmaceutical firms operating in the country. Currently, various state drug controllers are adopting disparate regulatory standards, precipitating a variety of issues such as misbranding (retaining the brand name after change of ingredients), circumvention of regulatory procedures for launch of new drugs etc.

In the past five years, the central government has taken a slew of legislative steps, aimed at making globally-compliant laws for drug and cosmetics regulation. These included revamp of the Schedule Y of the Drugs & Cosmetics Act dealing with clinical trials , legal system for registration for imported drugs etc.

Systems have been created for approvals for new drugs and biotech drugs. However, the administrative set-up has not moved in tandem with these changes.

WHAT THE PROPOSED CENTRAL DRUG REGULATOR
WILL DO?

New Delhi Economic Times 5th February 2007:

India’s pharmaceutical companies are getting footprints in the highly regulated western markets in a rapid fashion through organic and inorganic forays, but the drug regulatory system in the country is grossly inadequate and slothful, despite that recent years saw a host of domestic laws and regulations being attuned to the best global practices.

Last month, the cabinet approved the health ministry’s plan to set up the Central Drug Authority (CDA) of India , an idea which was hanging fire for years, despite several expert committees iterating the need for not only reinforcing the regulatory resources but also a power shift from the states to the centre.

Why the CDA?

First, it requires high levels of technical competence and assiduity to evaluate the applications for introduction of “new drugs” in the market. (Each new drug application consists of a large volume of data to support the efficacy, safety (tolerable toxicity) and dosage directions which have to be vetted).
Currently, drug licensing powers are vested with state governments.

The regulator at the centre- the Drugs Controller General of India (DCGI) in the central drug standard control organisation- approves new drugs (first introduced in the world less than four years ago), vaccines and serums as well as regulates export and import of drugs. Disparity in licensing standards among states and their non-compliance with DCGI’s directions have been a major reason for proliferation of irrational drugs, mainly fixed dose combination drugs, in the market. The plan, therefore, is to remove drug licensing power from states and vest that with the CDA.

Further, India is being seen as an ideal laboratory by global pharmaceutical inventors who want to test and validate their drug candidates by administering them in humans in leery doses thanks to the rich genetic diversity the sub-continent is pre-disposed to. The trials of candidate drugs in humans (known as clinical trials) is the most risky and the most expensive phase of new drug development and is already a $250 million market in India with pharma MNCs employing contract research organisation to perform these trials here. The rush is such that almost every alternate day, the DCGI clears an application for such drug trial. This is an expediency which demands proper, informed and earnest regulation of trials in human volunteers, and avoiding such activities taking place surreptitiously which could have untoward consequences.

“Multinational pharma companies are increasingly unable to recruit adequate number of people for conducting clinical trials in their own countries. The proposed CDA would help create the regulatory resources in India for high quality assessment of clinical trials data,” says Dr Arun Bhatt, president, Clininvent, a CRO.

There are also other important objectives of drug regulation like ensuring Good Manufacturing Practices (GMP), frustrating production and marketing of spurious drugs, monitoring adverse drug reactions (post-marketing surveillance) and so on, all a resourceful CDA could better.

The proposed central authority is in fact belated attempt to equip the drug regulator with enough resources. It is envisaged to be fully autonomous and financially self-sustaining- it will fend for itself by charging fees for various regulatory services and will be housed in an own Foods and Drugs Bhawan in the Capital. It will be headed by the DCGI, a technical expert in the rank of additional secretary to the government of India, who will be supported by an additional drug controller in the rank of joint secretary.

The plan is that authority would be modelled on the lines of the US’ federal drug regulator- the United States’ Food & Drugs Administration (US-FDA). The CDAI would constantly interact with the drug regulators abroad to harness regulatory expertise. It will have 10 separate divisions for licensing, research, Indian systems of medicine etc., with a view to giving regulatory oversight of clinical trials, new drugs, medical devices, cosmetics, vaccines & biologicals, GMP-compliance etc.

Says former DCGI Ashwini Kumar, “centralised drug licensing would help introduce a level-playing field for the pharmaceutical firms operating in the country. Currently, various state drug controllers are adopting disparate regulatory standards, precipitating a variety of issues such as misbranding (retaining the brand name after change of ingredients), circumvention of regulatory procedures for launch of new drugs etc.”

Centralisation has already been kick-started. Recently, the centre has taken the power to approve brands. Also, the states have been sternly told that they won’t issue licences for new drugs, without the central regulator’s prior consent. The CDAI would take this process forward.

The Authority, to be assisted by an advisory board, would streamline the process of drug manufacture in the country and also be an effective monitor. Not that the proposal has gone down well with all concerned. “It is difficult to create enough manpower with the centre overnight. Instead, state drug control units could be merged to create one entity which the centre will supervise,” says Ravi Uday Bhaskar, secretary-general, All India Drug Control Officers’ Confederation. Over the years, due to retirements, the staff strength of the present central regulator has reduced to almost a fifth of what it used to be a decade ago.

Nevertheless, in the past five years, the centre has taken many legislative steps to make globally-compliant laws for drug regulation: revamp of the Schedule Y of the Drugs & Cosmetics Act dealing with clinical trials, legal system for registration for imported drugs, new GMP norms, systems for approvals for biotech drugs etc. However, the administrative set-up has not improved in equal pace.

Says Brijesh Regal, CEO of New Delhi-based Apothecaries Clinical Research, “If the CDAI takes shape in the way it is proposed, it would address the concerns in the areas of regulation of clinical research and drug safety. In manufacturing, India is already at par with the best in the world. The proposed authority would boost the initiatives in adverse drug reaction monitoring which needs greater manpower.” The Parliament will have to approve a few amendments to the Drugs & Cosmetics Act to establish the CDA.
However, a question which the CDA, in the form now being planned, might not address is the gawky separation of drug pricing regulation from quality control, even though these functions sometimes move in conjunction.