Drug regulatory system set to get Make in India, ease of doing biz makeover.

The government has decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, and replace it with a new one keeping in mind advancements in the therapeutic sphere and in stem cell research, clinical trials, regenerative medicines, and also in online sale of medicines and medical devices.

The review of the existing law will be in line with the Make-in-India initiative to facilitate the ease of doing business and enhance the quality and efficacy of pharmaceuticals.

Though the regulatory framework for ensuring quality, safety and efficacy of medical products is provided for in the Drugs and Cosmetics Act, 1940, it regulates only conventional pharmaceuticals, which account for R1 lakh crore of annual domestic sales. India is one of the largest manufacturers of pharmaceuticals with annual production valued at over R2 lakh crore. Of this, 55% is exported, including to developed countries, helping them manage their public healthcare system at substantially lower costs. “In order to leverage the comparative cost advantage, the demographic dividend and the advantage in IT, the Indian medical products sector is poised for exponential growth. Besides meeting domestic demand, it has the potential to become a global hub for manufacturing,” the government statement said.

The health ministry has undertaken an exercise at two levels. One, to frame separate rules under the existing Act for regulating medical devices and, two, to bring out separate legislations for regulating medical devices, and drugs and cosmetics. Work on drafting the new legislation has commenced. In January, it released the proposed Drugs and Cosmetics (Amendment) Bill, 2015, which had provisions for penalty and even jail for those who do not follow the protocol for clinical trials. The new version primarily deals with clinical trials and medical devices.

In 2013, the UPA had tabled a similar Bill in the Rajya Sabha, which was opposed by several members. The 2013 Bill had provisions for setting up of a Central Drugs Authority as a 19-member overarching body for regulation of drugs and cosmetics—which was to be headed by secretary, health & family welfare—and sought to bring 17 critical drugs under central licensing. Subsequently, the Bill was sent to a Parliamentary Standing Committee. The NDA has decided to draft an altogether fresh Bill.

Dr Rao Vadlamudi, president, Indian Pharmaceutical Association (IPA), is of the opinion that the country needs a uniform regulatory regime.

“A multiplicity of regulatory agencies creates confusion. We need clarity over which is the nodal ministry that will give permissions. As of now, there is an overlap. There is always some or the other conflict between two authorities/ministries. Even dispute between two departments gets buried and remains unresolved for a long time. These roadblocks need to be cleared in the proposed Bill,” he said.

According to him, although India is a major manufacturer of generic drugs, it is dependent on imports for life-saving biotechnology-based drugs that can treat cancer, hepatitis and autoimmune diseases, and for majority of medical devices and diagnostics.

“My understanding is the government wants to create a platform for manufacture of even these. It should first have a strong centralised regulatory regime with greater coordination, accountability and transparency in functioning among different ministries concerned with drug regulation,” he added.

As of now, the Central Drugs Standard Control Organisation (CDSCO)—under the ministry of health & family welfare—prescribes standards for ensuring safety, efficacy and quality of drugs, regulates market authorisation of new drugs and clinical trials standards, and supervises drug imports and approves licenses to manufacture above-mentioned products. Then there is National Pharmaceutical Pricing Authority—under the Department of Chemicals & Petrochemicals—which fixes or revises prices of decontrolled bulk drugs and formulations, and maintains data on production, exports, imports and market share of pharmaceutical firms. Pharmaceutical regulation is thus divided between the two ministries. The health ministry examines pharmaceutical issues within the larger context of public health, while the focus of the ministry of chemicals & fertilisers is on industrial policy. Ministries of environment, finance, commerce & industry and science & technology also play a role in the regulation process. State drug controllers have the authority to issue licences for the manufacture of approved drugs and monitor quality control, along with CDSCO.

The IPA had suggested review of conflicting provisions in the 2015 Bill, including the one that gave power to the central government to suspend/cancel permission/licence granted by the state licensing authorities in the interest of public health.

According to Dheeraj Nair, partner with law firm J Sagar Associates, we need proper regulatory expertise, transparency in licensing procedures, testing facilities to implement uniform standards and thrust on institutional support to small-scale firms before striving to make India a manufacturing hub.

Greater clarity on patentability of pharmaceuticals and terms for compulsory licensing to prevent legal disputes should be also looked into, an IPR expert said, adding that severe penalties for spurious and adulterated drugs should be incorporated in the proposed legislation. A study by a trade industry body had put spurious drugs at a high 30% of all drugs sold in India. Even separate courts for trying such offences is also desirable, a government lawyer said.

Credit- The Financial Express

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