Generic drug

This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.

1. School of Public Health 16-01-2018 1 SEMINAR GENERIC DRUG Name: Shubha Ranjan Jena Course : MPH Roll No : 173600 5

2. CONTENT: What is Generic drug? Why Generic Drug was needed? What is the Advantages of Generic Drug? What is the Disadvantages of Generic Drug? Reason behind unpopularity of generic drugs in India? Why Generic Drugs are important in India? Why there is a need Generic drug policy? Regulatory Authority? What are the act & laws? What policy existing in India for generic medicine? Conclusion 16-01-2018 2

3. 16-01-2018 3 Generic Drug A generic drug is a medication that has exactly the same active ingredient as the brand-name drug and yields the same therapeutic effect. It is the same in dosing, safety, strength, quality, the way it works, the way it is taken, and the way it should be used. Generic drugs do not need to contain the same inactive ingredients as the brand name product. However, a generic drug can only be marketed after the brand-name drug's patent has expired, which may take up to 20 years after the patent holder’s drug is first filed with the U.S. Food and Drug Administration (FDA).

4. 16-01-2018 4 Generic drugs  are usually much less expensive than brand name drugs once they reach the market . A drug company develops new drugs as brand-name drugs under patent protection. This protects their investment in drug research by giving the drug company the sole right to manufacture and sell the brand-name drug while the patent is in effect.

5. 16-01-2018 5 Why Generic Drug was needed? As we shall see, very often the cost difference is so much that even well to do people cannot afford a branded drug while the generic version can be afforded. India is a Developing country so people can’t afford branded drug.

6. What is the Advantages of Generic Drug? These drugs are comparatively cheaper. They save out of pocket expenditure on the part of the patient . Generic Drugs also break the nexus between the pharmaceutical companies and the doctors, in which the doctors are given incentives, gifts etc to promote a specific brand of medicine. Often, it causes the doctors to prescribe expensive medicines (although, the cheaper versions are available) which increase the burden on the patient.

7. 16-01-2018 7 The generic medicines have also found an attractive market overseas. A number of Indian pharmaceutical companies have taken advantage of this and have been exporting these drugs to both developed and developing nations. This earns the pharmaceutical companies a considerable volume of foreign exchange. It not only helps the pharmaceutical sector, but it also makes Indian pharmaceutical industry recognized on a global scale. Such pro fi ts also increase the capacity of the pharmaceutical companies to invest in research and development. Increase access to health care for the majority. Peoples are not facing any financial hardship. Patient can easily access and afford the cost of generic drug. So it’s help to achieve Universal Health Coverage.

8. 16-01-2018 8 What is the Disadvantages of Generic Drug? Generic Drugs are not possible in all cases. Because its takes long time to expire any patent. Reason behind unpopularity of generic drugs in India? In India people are influenced by the “brand name” of a product whether it may be clothes, cosmetics, accessories, including grocery, durables or medicines. Even in the case of the medicines market, the brand names are more popular. Certain names of medicines have a powerful impact on people’s minds that both the medicine and the brand have become synonymous.

9. 16-01-2018 9 Another reason is lack of awareness about generic drugs. Even there is a certain section of the population who feels that since these are comparatively cheaper, they may be of inferior quality. Chemists give medicines that are written on the prescription and in most cases, the doctors don’t prescribe generic drugs. Reason behind unpopularity of generic drugs in India? One has to understand that several branded drugs for treating lifestyle diseases like diabetes, cancer, hypertension, etc. are highly expensive and physicians usually prescribe these branded products.

10. 16-01-2018 10 Therefore to promote the use of cheaper generic substitutes popular in the country, physicians support is the most critical factor. It is only now the health ministry decided to make it mandatory for all the physicians in the country to prescribe drugs with generic names. This is going to be a great challenge. Reason behind unpopularity of generic drugs in India? Several countries including those in the developed world are seriously trying to promote the use of generic drugs for their citizens today. In India with huge poor and sick population, the government should have seriously attempted popularizing the use of generics nationwide long back. The Government is also to blame for the lack of awareness. The Department of Pharmaceuticals has failed to do enough promotion of generic drugs and the proper implementation of the Jan Ausadhi scheme. Launching of Jan Aushadhi stores by the Central government in 2008 to promote the use of generic drugs was a well intended Central programme but it has not taken off yet.

11. 16-01-2018 11 Why Generic Drugs are important in India? Poverty is a significant issue in India. The World Bank reviewed and proposed revisions in May 2014, to its poverty calculation methodology and purchasing power parity basis for measuring poverty worldwide, including India. According to this revised methodology, the world had 872.3 million people below the new poverty line, of which 179.6 million people lived in India. In other words, India with 17.5% of total world's population, had 20.6% share of world's poorest in 2011. So the main important is that the generic drugs are comparatively cheaper than their branded counterparts. It will allow the drugs to be more accessible and will reduce the out of pocket expenditure on the parts of the patient family.

12. 16-01-2018 12 Why there is a need Generic drug policy? Lack of access to essential medicines for non communicable diseases is a major challenge for the health systems in many low-resource countries, potentially contributing to increased mortality and morbidity in these countries. The World Health Organization (WHO) has recommended that every country should have a national drug policy that ensures access, quality and rational use of medicines as an integral part of its broader strategic health-care policy. It has also recommended that non communicable diseases be incorporated into the strategic plans of national drug policies. The WHO Model list of essential medicines  contains 95 basic medicines for most non communicable diseases, including 16 new medicines for cancer that were added in May 2015. Despite the wide adoption of national drug policies in low- and middle-income countries, the majority of these do not include essential medicines for non communicable diseases.

13. 16-01-2018 13 Based on the WHO essential medicines concept, the national drug policy identified 150 essential drugs for controlled pricing. The policy was instrumental in improving the supply and accessibility of quality essential drugs at an affordable price. Why there is a need Generic drug policy? Most non communicable diseases can be treated or managed with a small range of low-cost generic medicines such as anti- hypertensives , statins and other cardiovascular drugs, analgesics, anti-asthmatics and some common anti-cancer drugs .

14. 16-01-2018 14 Regulatory Authority? 1-The Central Drug Standards and Control Organization ( CDSCO ) CDSCO functions under the Ministry of Health and Family Welfare Prescribes standards and measures for ensuring the safety, efficacy, and quality of drugs, cosmetics, diagnostics and devices in the country; Regulates the market authorization of new drugs and clinical trials standards; Supervises drug imports and approves licenses to manufacture the above-mentioned products;

15. 16-01-2018 15 2--The National Pharmaceutical Pricing Authority ( NPPA ), 1997 Regulatory Authority? The NPPA functions under the Department of Chemicals and Petrochemicals. Fixes or revises the prices of decontrolled bulk drugs and formulations periodically Updates the list under price control through inclusion and exclusion of drugs in line with prescribed guidelines priodically Maintains data on production, exports and imports and market share of pharmaceutical firms;

16. 16-01-2018 16 The Ministry of Health and Family Welfare examines pharmaceutical issues within the larger context of public health while the focus of the Ministry of Chemicals and Fertilizers is on industrial policy. In July 2008,the cabinet Secretariat, created a new department under Ministry of Chemicals and Fertilisers – the Department of Pharmaceuticals, with the objective of giving greater focus and thrust on the development of Pharmaceutical Sector in India and to regulate various complex issues related to pricing and availability of affordable medicines, research & development, protection of intellectual property rights and international commitments related to pharmaceutical sector which require integration of work with other ministries.

17. 16-01-2018 17 What are the act & laws? The Drugs (Amendment) Act, 1955 (11 of 1955) The Drugs (Amendment) Act, 1960 (35 of 1960) The Drugs (Amendment) Act, 1962 (21 of 1962) The Drugs and Cosmetics (Amendment) Act, 1964 (13 0f 1964) The Drugs and Cosmetics (Amendment) Act, 1955 19 of 1972) The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982) The Drugs and Cosmetics (Amendment) Act, 1986 The Drugs and Cosmetics (Amendment) Act, 1995 (71 of 1995) Narcotic Drugs And Psychotropic Substances Act The Patents Act Right To Information (RTI) Act

18. 16-01-2018 18 What policy existing in India for generic medicine? Making quality medicines available at affordable prices for all, particularly the poor and disadvantaged, through exclusive outlets " Jan Aushadhi Medical Store ", so as to reduce out of pocket expenses in healthcare. In September 2015, the ' Jan Aushadhi Scheme ' was revamped as ' Pradhan Mantri Jan Aushadhi Yojana ' (PMJAY). In November, 2016, to give further impetus to the scheme, it was again renamed as " Pradhan Mantri Bhartiya Janaushadhi Pariyojana " (PMBJP). I-- Pradhan Mantri Bhartiya Janaushadhi Pariyojana " (PMBJP)

19. 16-01-2018 19 Pradhan Mantri Bhartiya Janaushadhi Pariyojana  (PMBJP) is a campaign launched by the Department of Pharmaceuticals to provide quality medicines at affordable prices to the masses. PMBJP stores have been set up to provide generic drugs, which are available at lesser prices but are equivalent in quality and efficacy as expensive branded drugs.

20. 16-01-2018 20 II—NATIONAL HEALTH POLICY: Drug Regulation: Prices and availability of drugs are regulated by the Department of Pharmaceuticals. However, with regard to other areas of drugs and pharmaceuticals, this policy encourages the streamlining of the system of procurement of drugs; a strong and transparent drug purchase policy for bulk procurement of drugs; and facilitating spread of low cost pharmacy chain such as Jan Aushadhi stores linked with ensuring prescription of generic medicines. It further recommends education of public with regard to branded and non-branded generic drugs. The setting up of common infrastructure for development of the pharmaceutical industry will also be promoted. The policy advocates strengthening and rationalizing the drug regulatory system, promotion of research and development in the pharmaceutical sector and building synergy and evolving a convergent approach with related sectors.

21. 16-01-2018 21 Pricing- Drugs, Medical Devices and Equipment: The regulatory environment around pricing requires a balance between the patients concern for affordability and industry‟s concern for adequate returns on investment for growth and sustainability. Timely revision of National List of Essential Medicines (NLEM) along with appropriate price control mechanisms for generic drugs shall remain a key strategy for decreasing costs of care for all those patients seeking care in the private sector. An approach on the same lines but suiting specific requirements of the sectors would be considered for price control with regard to a list of essential diagnostics and equipment.

22. 16-01-2018 22 Availability of Drugs and Medical Devices: The policy accords special focus on production of Active Pharmaceutical Ingredient (API) which is the back-bone of the generic formulations industry. Recognizing that over 70% of the medical devices and equipments are imported in India, the policy advocates the need to incentivize local manufacturing to provide customized indigenous products for Indian population in the long run. The goal with respect to medical devices shall be to encourage domestic production in consonance with the “Make in India” national agenda. Medical technology and medical devices have a multiplier effect in the costing of healthcare delivery. The policy recognizes the need to regulate the use of medical devices so as to ensure safety and quality compliance as per the standard norms.

23. 16-01-2018 23 Conclusion India has industry oriented drug policy, National Health policy but we do not have patient friendly National Medication policy for patient safety.

24. 16-01-2018 24 Reference: https://www.india.gov.in/spotlight/pradhan-mantri-bhartiya-janaushadhi-pariyojana http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1888 - https://blog.ipleaders.in/generic-drug / https:// www.drugs.com/generic_drugs.html https:// www.pharmatutor.org/articles/why-generic-drugs-not-so-popular%3F http://www.who.int/bulletin/volumes/95/5/15-161117/en/

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