PHARMA POLICY OF GOVT OF INDIA

INTRODUCTION

India's pharmaceutical sector will touch US$ 45 billion by 2020,
according to a major study by global management and consulting firm,
McKinsey & Company. The reasons for this optimism are well founded.
In the period 2002-2012, the country's healthcare sector grew three times
in size, touching US$ 70 billion from US$ 23 billion. India's
pharmaceutical market experienced a similar boom, reaching US$ 18
billion in 2012 from US$ 6 billion in 2005. The report further states that
the Indian pharmaceutical market will be the sixth largest in the world by
2020.

The rise of pharmaceutical outsourcing and investments by
multinational companies (MNCs), allied with the country's growing
economy, committed health insurance segment and improved healthcare
facilities, is expected to drive the market's growth.

India is today one of the top emerging markets in the global
pharmaceutical scene. The sector is highly knowledge-based and its
steady growth is positively affecting the Indian economy. The organized
nature of the Indian pharmaceutical industry is attracting several
companies that are finding it viable to increase their operations in the
country.

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biologics which are different from chemical compositions. PHARMA POLICY OF GOVT OF INDIA INDIAN PHARMACEUTICAL INDUSTRY POLICIES & ORDERS When we talk about pharmaceutical policy. Let us discuss the main pharmaceutical policies of India under the following heads:  Drugs Price Control Order (DPCO): Drugs and formulations have been subjected to price control from a very long time. 2 . considering both brand name and generic drugs. Price control in a large number of industries has already been abolished. The economic reforms presented by the Government of India in July 1991. Pharmaceutical policies also cover products derived from living sources referred as. vaccines and natural health products.  Intellectual Property Rights (IPR): The Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS) provides for minimum norms and standards in certain categories of intellectual property rights which are discussed in this section. targeted the Pharmaceutical Industry only in 1994 and that too partially. it implies a branch of health policy that covers various aspects of the pharmaceutical industry like as the development of new medicines. almost 3 decades now. provision and use of medications within a health care system.

Check in details the pharmaceutical policy 2002. 3 . PHARMA POLICY OF GOVT OF INDIA  Pharmaceutical Policy 2002: The basic objectives of Government's Policy relating to the drugs and pharmaceutical sector were enumerated in the Drug Policy of 1986.

HYPOTHESIS AND ENVIRONMENTAL RISK ASSESSMENT OF PHARMACEUTICALS 4 . PHARMA POLICY OF GOVT OF INDIA OBJECTIVES OF THE POLICY Key criteria for the inclusion of policy objectives into the study were: being frequently mentioned in literature and relevant policy documents (e.g. the following seven policy objectives were chosen:  Timely access to medicines  Equitable access to medicines  Reward for innovation  Cost-containment / control of pharmaceutical expenditure/budget  Long-term sustainability (for the health care system)  Promotion of a more rational use of medicines  Increased competition. As a result. the limitations related to the scope (too broad objectives or those already captured by other terms) were the criteria for exclusion. WHO Nairobi Declaration) and being identified as objective(s) by the High Level Pharmaceutical Forum or other key processes. Pharmaceutical Sector Inquiry.

For how many years you are practicing as a medical practicener (Doctor)? 5 . and finds that few studies include plasma concentrations and mode of action based effects. it should be possible to predict the potential environmental impact from information obtained during the drug development process. well below acute toxic levels. but there are uncertainties regarding the effects of chronic exposures and there is a need to priorities which pharmaceuticals may be of concern. There is a need for large-scale studies to generate robust data for testing the read-across hypothesis and developing predictive models. as they are ubiquitous in rivers and waterways. This paper critically reviews the evidence for read-across. If this holds true for different classes of pharmaceuticals. resulting in a (specific) pharmacological effect only if plasma concentrations are similar to human therapeutic concentrations. DATA ANALYSIS 1. Thus. Concentrations are in sub-ng to low μg/L. PHARMA POLICY OF GOVT OF INDIA Pharmaceuticals in the environment have received increased attention over the past decade. despite a large number of apparently relevant papers and a general acceptance of the hypothesis. there is an absence of documented evidence. the only feasible approach to protecting the environment. The read-across hypothesis stipulates that a drug will have an effect in non-target organisms only if the molecular targets such as receptors and enzymes have been conserved.

PHARMA POLICY OF GOVT OF INDIA  Less than one year ---------------------------------. 2. 12 per cent  Can not remember --------------------------------. 37 per cent 6 . 17 per cent  From one to five years ----------------------------. 32 per cent  Five to Ten years ----------------------------------. Great care was taken to ensure that the sample is adequate and representative of the universe. 36 per cent  More than Ten years ------------------------------. an attempt was made to understand the profile of the doctors in terms of their experience in the industry. 43 per cent  Strongly Agree --------------------------. 03 per cent Practicing as a medical practicener Interpretation: At the initial stage of the research. Do you agree that India’s pharmaceutical industry is one of the fastest growing segments of the Indian economy?  Agree -------------------------------------.

04 per cent  Do not know/ Can not say ------------. 09 per cent  Strongly Disagree ----------------------. 7 . PHARMA POLICY OF GOVT OF INDIA  Disagree ---------------------------------. 07 per cent The fastest growing segments of the Indian economy Interpretation: India’s pharmaceutical industry is one of the fastest growing segments of the Indian economy and this is also one of the vital industrial segments which are directly related to the health of the nation.

50 per cent  Strongly Agree ------------------------. This is what necessitates the pharmaceutical sector to formulate a unique marketing strategy to suit their industry requirements and that appears to be different. 32 per cent  Disagree -------------------------------. from other industries. 04 per cent  Do not know/ Can not say ---------. PHARMA POLICY OF GOVT OF INDIA 3. 8 . 10 per cent  Strongly Disagree -------------------. 04 per cent Pharmaceutical segments Interpretation: The structure and the dynamics of the pharmaceutical industry are different from that of other industrial domains. in practice and normative sphere. Do you agree that the marketing strategy of the pharmaceutical industry should be different from the marketing strategy in non-pharmaceutical segments?  Agree -----------------------------------.

10 per cent Pharmaceutical market in India Interpretation: In general. 10 per cent  Strongly Disagree --------------------. PHARMA POLICY OF GOVT OF INDIA 4. business in pharmaceutical market is conducted in two major ways. 9 . The respondents were of the opinion that institutional selling is quite prevalent in the Indian pharmaceutical industry. 06 per cent  Do not know/ Can not say -----------. 30 per cent  Disagree -------------------------------. that is. Do you agree that institutional selling is quite prevalent when it comes to pharmaceutical market in India?  Agree ------------------------------------. either by institutional selling or through trade business. 44 per cent  Strongly Agree ------------------------.

01 per cent  Strongly Disagree ----------------------. 02 per cent Innovative and better promotional measures for selling their products Interpretation: Even though it appears to be a serious industry on which the health of the nation rests. 00 per cent  Do not know/ Can not say ------------. 10 . 60 per cent  Strongly Agree --------------------------. PHARMA POLICY OF GOVT OF INDIA 5. Do you agree that the pharmaceutical companies need to use innovative and better promotional measures for selling their products?  Agree -------------------------------------. a deeper understanding of the industry will make it clear that business practices and sales promotion measures are a common thing and gradually becoming more aggressive and competitive among the pharmaceutical companies in India. 37 per cent  Disagree ---------------------------------.

The practice of offering gifts to the doctors to influence their prescriptions is a common strategy among the pharmaceutical companies. 95 per cent  No --------------------------------------------. PHARMA POLICY OF GOVT OF INDIA 6. 11 . the question is whether promotion is (as most drug companies claim) primarily information on how the drug works or is intended to persuade doctors to prescribe the drug more frequently. Does the Pharmaceutical Company offer gifts to the doctors to influence their prescriptions in favour of their company medicines?  Yes -------------------------------------------. In the case of marketing directly to health professionals. 01 per cent  Do not know/ Can not say ----------------. 04 per cent Prescriptions in favour of their company medicines Interpretation: Pharmaceutical marketing experts are aware that well timed advertising directed to doctors tends to boost sales of the brand that spent the marketing dollars.

12 . 15 per cent Promotional strategy of pharmaceutical companies Interpretation: The promotional strategy of the pharmaceutical companies is more oriented towards persuading the doctors to prescribe their products and the patients to purchase their products than simply to display information on the quality and availability of the product. 60 per cent  Other motives -------------------------------------------. Out of the following which one is more correct when it comes to the promotional strategy of pharmaceutical companies in the view of the doctors?  They aim to inform about the product ----------------. PHARMA POLICY OF GOVT OF INDIA 7. 03 per cent  Do not know/ Can not say ----------------------------. This is one criterion which makes the marketing strategy of the pharmaceutical companies different from that of others. 22 per cent  They aim to persuade to purchase --------------------.

03 per cent  Do not know/ Can not say -----------. 52 per cent  Strongly Agree ------------------------. Do you agree that unethical standards exist in the promotion of pharmaceutical products in India?  Agree ------------------------------------. 13 . PHARMA POLICY OF GOVT OF INDIA 8. 20 per cent  Disagree -------------------------------. It is for the government. 20 per cent  Strongly Disagree --------------------. It is an accepted fact that the promotional measure does contain unethical practices. 05 per cent Promotion of pharmaceutical products in India Interpretation: Adherence to ethical standards while pursuing the promotional strategy for selling their products is a concern in the pharmaceutical industry. the industry and the consumers to put a comprehensive effort to ensure that the practices of unethical standards are withdrawn from the health industry.

PHARMA POLICY OF GOVT OF INDIA 9.67 per cent  Ensure codes of conduct on drug promotion ------------------. It is equally important that health professionals have access to independent and up to date advice on medicines so that they can make informed judgments about the most appropriate medication for patients.  Implement.01 per cent The industry and government regarding Interpretation: Whilst the pharmaceutical industry clearly has an important role to play in tackling the health challenges their involvement in the promotion of medicines presents a serious conflict of interest.70 per cent  Other measures ----------------------------------------------------. 14 .86 per cent  Stop the practice of gifts to doctors ----------------------------. improve and monitor legislation ----------------.12 per cent  Do not know/ Can not say ---------------------------------------.74 per cent  Measures to improve the transparency of drug companies’ marketing activities ---------------------------------------------. Your recommendation to the industry and government regarding the promotional strategy of the pharmaceutical companies? You can choose more than one option.

54 per cent  Do not know/ Can not say--------------------. PHARMA POLICY OF GOVT OF INDIA 10. 36 per cent  No -----------------------------------------------. Do you think that the entry of Multinationals is a Major Challenge to the domestic Players in the Pharmaceutical Market and are they ready to face the Challenges of the Foreign Players?  Yes ----------------------------------------------. 10 per cent The Challenges of the Foreign Players 15 .

23 PER CENT  B2C -------------------------------------------------------------32 per cent  Both -------------------------------------------------------------45 percent Market size 16 . PHARMA POLICY OF GOVT OF INDIA 11. What type of Marketing Strategy would you prefer to expand your Market size?  B2B-------------------------------------------------------------.

PHARMA POLICY OF GOVT OF INDIA 12. 24 per cent  B2C ------------------------------------------------------------. What type of Marketing Strategy does you as More Profitable?  B2B-------------------------------------------------------------. 31 percent More Profitable 17 . 47 per cent  Both ------------------------------------------------------------.

PHARMA POLICY OF GOVT OF INDIA CONCLUSION Implement. Take measures to improve the transparency of drug companies’ marketing activities and seriously address the conflict of interest encountered in drug companies’ funding of medical education. Support the provision of independent information on drugs for consumers and health professionals. Enforce strict sanctions that will deter poor corporate practice in drug promotion. Whilst the pharmaceutical industry clearly has an important role to play in tackling the health challenges their involvement in the promotion of medicines presents a serious conflict of interest. Ensuring high standards in the promotion of medicines is important to consumers’ health and helps to save money for health providers and patients. Implement and enforce a ban on gifts to doctors. Without proper controls consumers can be subject to misleading or inaccurate claims and the promotion of expensive branded medicines that have no greater medical value than cheaper non-branded products. improve and monitor legislation in line with the WHO Resolution on the Rational Use of Medicines and the WHO Ethical Criteria for Medicinal Drug Promotion. 18 .