A group of prominent NGOs in the healthcare sector has suggested the Central Government to formulate a National Pharmaceutical Policy considering the new product patent regime and factors like globalisation, liberalization and privatization affecting the availability and affordability of essential medicines in the country.
The NGOs led by the Jan Swasthya Abhiyan, Federation of Medical and Sales Representatives' Associations of India, National Campaign Committee for Drug Policy and All India Drug Action Network and supported by the World Health Organisation, India country office, has come out with a 'Kolkata Declaration' in this regard based on a workshop organised in Kolkata a few months ago. One hundred and twenty eight activists, academics and industry professionals from all parts of the country had attended the meet, which deliberated on different issues related to the pharmaceutical sector in India.
The declaration suggested formulating a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. An intersectoral committee of the ministry of health & family welfare and ministry of chemicals & fertilizers should prepare this policy after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from health movements, suggested the declaration.
The National Essential Medicines List (NEML) have to be updated by the government based on epidemiological data and should prepare a Graded Essential Medicines List that is appropriate for each level of the healthcare system. This list needs to be adopted and adapted by different states based on local conditions and disease profile. The government should monitor and ensure the availability of medicines listed in the EML. Production of these medicines from the basic stages should be ensured through production control mechanisms. Further, it should be made mandatory that the procurement and use of medicines in government hospitals and public sector undertakings be done based on the NEML. Such procurement should be through transparent procedures. Regular training and incentives to promote use of medicines in the NEML should be provided.
Further, the document has suggested that given the proliferation of irrational and hazardous medicines in the market, a special committee of the DTBA should be set-up to weed out all such medicines including irrational Fixed Dose Combinations (FDC) within a stipulated period. Hence, forth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should be banned and should not be allowed to be marketed. All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy and need. Injectable contraceptives, transdermal implants and anti fertility vaccines should not be used in the National Family Planning Programme. Adverse Drug Reaction (ADR) Monitoring Centres should be set up in all states of the country and be provided with sufficient resources. When a substantial number of ADRs are reported either in India or abroad for a drug, the same should be referred to the DTAB for withdrawal.
The Kolkata Declaration has also suggested critical policy changes in the areas of generic drug usage, medical education, Indian Patents Act, Drug production and availability, pricing, public sector units, R&D, Quality control and drug information, drug promotion etc. It noted that the country's record in controlling diseases that affected large sections of the people has been far less than satisfactory. The country faces new challenges in the form of increased incidence of "lifestyle" diseases and infections such as HIV-AIDS. This ominous situation admitted in the National Health Policy-2002 needs to be addressed seriously. Disease pattern and common ailments highlighted in NFHS-2 survey should also be taken in consideration, it suggested.