CINICAL RESEARCH

1. CINICAL RESEARCH

2. ACTS MAGIC REMIDIES & PRICE CONTROL

3. INDIA: Present Act & Rules • The Drugs and Cosmetics Act, 1940 • The Pharmacy Act, 1948 • The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 • The Narcotic Drugs and Psychotropic Substances Act, 1985 • The Medicinal and Toilet Preparations (Excise Duties) Act, 1956 • The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act)

4. The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 • This Act is meant to control the Advertisements regarding drugs; • it prohibits the advertising of remedies alleged to possess magic qualities and to provide for matters connected therewith.

5. The Drugs and Magic Remedies Act prohibits a person from taking part in publication of any advertisement referring to any drug which suggests use of the drug for: • the procurement of miscarriage in women or prevention of conception in women; and • the maintenance or improvement of the capacity of the human being for sexual pleasure; • the correction of menstrual disorders in women;

6. the diagnosis, cure, mitigation, treatment or prevention of any venereal disease. • It is prohibited to directly or indirectly give a false impression regarding the true character of a drug • or make false claim for it • or to convey any false or misleading information in any material particular about it. • No person shall import into or export from India any document containing advertisement of this nature.

7. Guilty? • Whoever contravenes the provisions of this Act shall, on conviction, be punishable with imprisonment which may extend to six months, with or without fine. • In case of subsequent convictions the imprisonment can be extended to one year. • The document, article or thing which contains the offending advertisement can be seized and confiscated. • If the person contravening any of the provisions of the Act is a company, every person who at the time the offence was committed was in charge of the business of the company shall be deemed guilty.

8. The prohibition under this Act does not apply to: a) any signboard or notice displayed by a registered medical practitioner including the treatment for any of the disease, b) any treaties or book dealing with any of the matters from a bonafide scientific standpoint, c) any advertisement related to any drug sent confidentially to any registered medical practitioners or to chemists for distribution among registered medical practitioners or to a hospital or laboratory, and d) Government advertisements.

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10. The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act) • In exercise of the powers conferred by section 3 of the Essential Commodities Act, 1955. • the Central Government makes the Order. • This Order may be called the Drugs (Prices Control) Order, 1995.

11. The Government may • with a view to regulate the equitable distribution and increasing supplies of a bulk drug , and making it available at a fair price from different manufacturers, • fix from time to time a maximum sale price at which such bulk drug shall be sold

12. The manufacturers should provide the purpose of enquiry, and other additional information. • The manufacturers should also allow for inspection of their manufacturing premises for verification through on the spot study of manufacturing processes and faculties and records.

13. fixing the maximum sale price • The Government shall take into consideration a post-tax return of fourteen percent on net worth or a return of twenty-two percent on capital employed. • An internal rate of return of twelve percent based on long term marginal costing

14. where the production is from basic stage • the Government shall take into consideration a post-tax return of eighteen percent on net worth or a return of twenty-six percent on capital employed. • And if once the rates are established, no change of rates shall be made without the prior approval of the Government.

15. No person shall sell a bulk drug at a price exceeding the maximum sale price fixed (plus local taxes, if any). • And until the price of a bulk drug is fixed, by the Government • the price of such bulk drug shall be the price which prevailed immediately before the commencement of this Order.

16. Any manufacturer, who desires revision of the maximum sale price of a bulk drug • shall make an application to the Government • and the Government will make an enquiry, within a period of four months from the date of receipt of the complete information, • fix a revised price for such bulk drug or reject the application for revision, documenting them with proper reasons. • Usage of form 1.

17. List of Price Controlled Drugs • SULPHAMETHOXAZOLE • PENICILLINS • TETRACYCLINE • RIFAMPICIN • STREPTOMYCIN • RANITIDINE • VITAMIN C

18. The Doha declaration:

19. Introduction • There are many wrong assumption regarding the price of a drug, specially regarding generics, and the market justification.

20. Wrong assumption #1: High price = High production cost Source: Doctors Without Borders, 2001

21. Wrong assumption #2: Profits are going into R&D

22. Wrong assumption #3: The pharmaceutical industry will suffer from generic competition • Africa represents only 1.3% of the pharmaceutical market, and according to pharma’s own employee, providing drugs for free in Africa would amount to little more than “three days fluctuation in exchange rates” (Washington Post, 2001) • Generic drugs have been produced cheaply in India for two decades, without infiltrating or undermining Western markets (Oxfam, 2003)

23. Pharma Profit Levels:

24. Problems with getting generics to the poor • The US Trade Representative (USTR) has threatened countries with trade sanctions if they try to import generics (Oxfam, 2002) • Even when not threatened, importing only patented drugs (without generic competition) reduces prices marginally, without helping most people (MSF, 2001) • Compulsory licensing helps more, but current rules make it almost impossible unless a country has pharmaceutical production facilities …most poor countries don’t (WTO, 2001)

25. A solution: the Doha Declaration • Trade ministers signed this agreement to fix the problems: • Preventing the USTR from threatening countries: “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health” • Helping poor countries: “we recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.”

26. The November 2001 declaration of the Fourth Ministerial Conference in Doha, Qatar, provides the mandate for negotiations on a range of subjects, and other work including issues concerning the implementation of the present agreements.

27. Did it work? • Before the deadline to potentially allow poor countries without manufacturing facilities to import generics: • The USTR called a private meeting in Sydney and threatened other countries that it would withdraw from its agreements on other issues (CPTech, 2002) • At the WTO Council Meeting weeks later, the USTR, under direct instructions from the White House, argued that the Doha Declaration was incorrectly written, and could not be enacted as planned (Financial Times, 2002) • Instead of finding a “solution”, the meetings broke down because the USTR refused to compromise

28. What happens now? • Many poor countries, which harbor 95% of those infected with HIV, along with thousands of sufferers from other treatable diseases, will not be able to import generic drugs unless this policy changes at the next WTO meeting (MSF, 2003) • On February 10th, the WTO council meeting will begin to decide if this will be allowed • Meanwhile, the USTR is trying to slip in stronger anti-generic rules into a Western hemisphere trade act called the Free Trade Area of the Americas (FTAA)

29. The difference between ability & character is, Ability will get us to the top. But, character will allow us to stay at the top