The public sector drug companies should take up a leadership role in the production of drugs for the masses and also in producing medicines for the neglected diseases, according the group of NGOs which have come up with the ‘Kolkata Declaration’.

The suggestion of NGOs assumes significance in the backdrop of the recent decision of the ministry of chemicals and fertilizers to revive all the five units of Indian Drugs and Pharmaceuticals Limited (IDPL) and other major public sector drug manufacturing units, as reported by Pharmabiz recently. The NGOs noted that availability of drugs for the poor and the neglected diseases could only be ensured by making public sector companies major producers in these areas.

Public sector companies such as IDPL and HAL should be revived and they should be provided with the support in the form of sectoral reservation, preferential treatment in the cases of Govt. purchases, etc. These companies would need to be provided a leading role in drug manufacture in the case of compulsory licenses issued in situations of national emergency and extreme urgency. New public sector companies should be promoted for producing those essential medicines that are not being produced by private companies at an affordable cost, suggested the document.

Further, the Declaration demanded the government to bring all drugs under price control and to constitute a National Medicines Pricing Authority armed with powers to punish manufacturers violating ceiling prices.

The document, being drafted by 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, noted that price control of all drugs is necessary considering the fact that drug expenditure in India is more than half the health care expenses and more than 80% of health care expenditure is met by patients themselves.

Mechanisms that are transparent and easy to administer should be put in place to control prices and the system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%. Trade margins, including those to the wholesalers and retailers, should not go beyond 30%. The government should establish the National Medicines Pricing Authority as a quasi-judicial body which should be given sufficient legal power to punish manufacturer for violation of ceiling prices to effectively ensure price control, suggested the Declaration.

For imported medicines, provision of cost data and manufacturers price certificate should be made mandatory. All cancer and HIV/AIDS medicines and orphan medicines should be exempt from all taxes and duties, including import duties.

The document said a major national effort is necessary to increase original drug research based on the strength of our national research institutes, laboratories and the Universities and also on the biodiversity and the medicinal plant wealth of our country. The research institutions should be provided with adequate funds for drug research. Regional drug research centres may be established in states where infrastructure facilities are already available. Universities should be encouraged to offer courses so as to produce adequate and high quality human resource pool for modern drug research related activities. The public sector should be promoted to play the leading role in R&D activities. Public funded research laboratories should co-ordinate their activities. The research activities of publicly funded research organisations should not duplicate empirical drug discovery projects in the pharma R&D model, but should concentrate on generating the knowledge base for the identification and exploitation of new intervention points for medicines. Further, all medicines developed in the country should be exempt from taxes and duties for 10 years, suggested the Kolkata Declaration.

On the emerging segment of clinical trials, the document said a comprehensive legislation on the ethical conduct of clinical trials should be enacted in line with the Helsinki Declaration and other international covenants, treaties and declarations so as to provide for strict guidelines for obtaining informed consent, for protection of the health of subjects of such trials. Outsourcing of clinical trials for MNCs should be closely monitored by a specially constituted Standing Ethics Committee set up in each state. All information about protocols and the results of the clinical trials approved by the DGCI should be in the public domain. Phase IV of the clinical trials should be mandatory and should not be replaced by the PMS studies by he pharmaceutical companies, said the Declaration.