The NGOs spearheading drug reforms has suggested constitution of an exclusive Food and Drug Court in the country for trial of spurious drug makers and redressal of all complaints relating to this illegal activity. Currently, mostly lower courts are handling the cases relating to manufacture and sale of fake and substandard drugs and they take several years to settle the cases.

Inordinate delay in adjudicating spurious drug cases has been a major issue in checking the growth of spurious drugs manufacture and sale for some time. In their ‘Kolkata Declaration,’ the group of NGOs led by Jan Swasthya Abhayan and FMRAI has demanded the government to suitably amend the Drugs and Cosmetics Act to provide for exemplary punishment to those engaged in this illegal activity. The document suggested that the manufacturer should be made fully responsible for the quality of all medicines marketed by them.

The NGOs also underlined the need for a comprehensive revamp of the drug administration in the country with a focus on quality control and effective monitoring of drug manufacturing activities. It further said the drugs control organization both at state and central levels should be adequately strengthened in terms of infrastructure facilities and human resources. Each state should have at least one well-equipped drug-testing laboratory under the control of the state drug controller.

The state and central drugs controllers should have their own websites. Among other information these websites should publish updated information on banned and withdrawn drugs including their brand names as well the current laws in operation. A consensus should be developed after discussion with manufacturers of all sectors for developing minimum benchmark of good manufacturing practice which then can be embodied in the Schedule M of the Drugs & Cosmetics Act. Besides, consumers should be allowed to get tested medicines of doubtful quality at any government approved test laboratory. New colleges of pharmacy should be opened to eventually ensure that all retail pharmaceutical outlets have the services of a trained pharmacist. The outdated Magic Remedies Act should be replaced by a new Act, they demanded.
 
To disseminate unbiased information of medicines, government should develop an independent process for information. The National Formulary should be updated and published regularly. Standard treatment protocols and guidelines for common ailments and for every tier of the health system should be prepared and disseminated. Doctors, pharmacists and staff nurses should be trained in treatment protocols and guideline. All hospitals and medical centres should be encouraged to prepare and use their own formularies.

Commenting on the need for regulating promotion of drugs, the document suggested constitution of a National Ethics Committee on Promotion of Medicines (NECPM) with adequate representative of civil society organisations to monitor all promotional efforts. A code of ethics for marketing of medicines should be adopted by NECPM and made obligatory for all the manufacturers. All promotional materials for health professionals should be screened and approved by NECPM and all advertisements in the regional press be scrutinized and approved by a state level Ethical Promotion Committee.

Further, gifts except minor items, inducements, sponsoring of meetings and entertainment of the members of the medical profession and those who are related to drug prescription, purchase etc. by drug companies should be banned so that these do not influence prescribing practices. Drug companies should contribute funds to the drug control authority for the conduct of Continuing Medical Education programme for doctors. A cap on drug promotional expenditure by drug companies should be fixed and enforced. In order to encourage use of medicines in generic names, all medicines sold under generic names should be exempt of duties and taxes. All packages of medicines should carry the generic name more prominently than the brand name, suggested the document.