The aura of change, which has been there in the air ever since the new government assumed power at the Centre in May last year, is there for everybody to feel. There is a positive business sentiment, positive change in mood of the people as a whole and there is vibrancy in the country, all emanating from the new government's promise of an Ache Din (better days) for one and all, including the industries which have been crying hoarse from the rooftops for quite a long time for policy initiatives by the government to stem the lingering rot.
And the government's promise of an Ache Din seems to be not a lip service, especially for the pharmaceutical industry, as various departments of the government have come out with a slew of policy measures to fill the policy deficit which has been the hallmark of the previous government.
The message is loud and clear. That the new government is not sitting in an ivory tower; and it means business. It is crystal clear from the fact that even though the government has not even completed a year in office, it has come out with policies which have been pending for several years. Moreover, it has constituted several high-level committees to recommend policy changes to make doing pharma business simpler and easier in the country.
In a major policy initiative, the Union Health Ministry has recently released the draft Drugs and Cosmetics (Amendment) Bill, 2015 which is intended to amend the Drugs and Cosmetics Act, 1940 for upgradation and introduction of provisions for clinical trials and regulation of medical devices in the country. The post-haste in which the ministry has finalised the Bill shows the intention of the government.
The Bill, which is expected to be tabled in Parliament during its next session, proposes to expand the scope of the Act to cover new areas and will “regulate the import, manufacture, distribution and sale of drugs, cosmetics, medical devices and conduct of clinical trials and for matters connected therewith or incidental thereto".
Expanding the scope of the Bill to medical devices and clinical trials is significant as streamlining of both these controversial sectors have been overdue in the country. The Bill proposes to insert a separate chapter on clinical trial, Chapter 4A, according to which “No person, sponsor, clinical research organisation or any other organisation or investigator, shall conduct any clinical trial in respect of a new drug, investigational new drug, notified category of new medical device and investigational new medical device, new cosmetic, bioavailability or bioequivalence study of any new drug, in human participants except under, and in accordance with, the permission granted by the Central Licensing Authority in such form and manner as may be prescribed”. he Bill also proposes to insert a separate chapter on medical device, Chapter IIA, on import, manufacture, sale and distribution of notified category of medical device.
Another major policy initiative of the Union Health Ministry is the issuance of the much awaited draft National Health Policy 2015 which is a declaration of the determination of the government to leverage economic growth to achieve health outcomes and an explicit acknowledgment that better health contributes immensely to improved productivity as well as to equity.
The policy addresses the urgent need to improve the performance of health systems in the country.
The National Health Policy 2015 aims to improve population health status through concerted policy action in all sectors and expand preventive, promotive, curative, palliative and rehabilitative services provided by the public health sector; achieve a significant reduction in out of pocket expenditure due to health care costs and reduction in proportion of households experiencing catastrophic health expenditures and consequent impoverishment; assure universal availability of free, comprehensive primary health care services, as an entitlement, for all aspects of reproductive, maternal, child and adolescent health and for the most prevalent communicable and non-communicable diseases in the population; and enable universal access to free essential drugs, diagnostics, emergency ambulance services, and emergency medical and surgical care services in public health facilities, so as to enhance the financial protection role of public facilities for all sections of the population.
The policy also aims to ensure improved access and affordability of secondary and tertiary care services through a combination of public hospitals and strategic purchasing of services from the private health sector; and influence the growth of the private health care industry and medical technologies to ensure alignment with public health goals, and enable contribution to making health care systems more effective, efficient, rational, safe, affordable and ethical.
The National Health Policy 2015 also aims to inform, clarify, strengthen and prioritize the role of the government in shaping health systems in all its dimensions- investment in health, organization and financing of healthcare services, prevention of diseases and promotion of good health through cross sectoral action, access to technologies, developing human resources, encouraging medical pluralism, building the knowledge base required for better health, financial protection strategies and regulation and legislation for health.
More recently, the Union Health Ministry has constituted a high level committee under the chairmanship of Joint Secretary (Regulation), Department of Health & Family Welfare, Ministry of Health & Family Welfare, for examining and recommending amendments in the Drugs and Cosmetics Rules, 1945.
The ministry decided to constitute this high level committee to expeditiously revisit the Drugs and Cosmetics Rules, 1945 and make recommendations for appropriate modifications/ changes thereon.
The committee will revisit the Drugs and Cosmetics Rules, 1945 and make recommendations for amending the same in order to make these rules contemporary while keeping in view the requirements of quality, safety and efficacy of medical products and also the efficiency of regulatory structures and the industry and to keep pace with changing scenario of drugs, medical devices and cosmetics industry.
In yet another major policydecision that will go a longway in boosting the saggingmorale of the medical devicesindustry in the country, theCentral governmentapproved 100 per cent FDI inmedical devices via automaticroute. Currently, the medicaldevices sector falls under thepharmaceutical category andis accordingly subjected toFDI limits and other conditionssuch as mandatory governmentapproval. While 100per cent FDI in permitted inthe pharma sector, the FDI ispermitted through automaticroute in the case of greenfieldinvestment or new ventureand the Foreign InvestmentPromotion Board (FIPB)approval is required in thecase of brownfield investmentor in existing companies.India imports about 70 percent of its requirement of medicaldevices. The industrysize in the country is aboutUS$ 7 billion.
Besides, it is just a question of a few months, if not weeks,when the new Central governmentrolls out the new bulkdrug policy which is expectedto be an industry-friendly oneand will remove all the existingirritants and prevailing ills thathave overtaken the pharmasector in the last few years,vastly restricting its growth.
The government had earlierconstituted a task force forpreparing the policy and it hasfinalized the recommendations.This has been sent to thePrime Minister's office which ispresently examining the recommendations.Since PrimeMinister Narendra Modiattaches so much of importanceto the pharma sector, heis keen to shape it up to meet itsfuture growth both in terms ofproduction and exports.