To achieve the objective of making available quality drugs in the country, Maharashtra Food and Drug Administration (FDA) has recommended certain suggestions to the Drug Consultative Committee (DCC) to bring in uniform regulations and enforcement related to the drug trade, Good Manufacturing Practices and regulation of medical devices to make it affordable to the common man.
FDA Commissioner Mahesh Zagade said the recommendations have been submitted in line with the Government of India's mandate that state regulatory authorities should act in a harmonious manner to achieve the objective of maintaining quality of the drugs
FDA Commissioner raised issues in the context of enforcement of the provisions of the Drugs and Cosmetics Act, 1940 stating that there are three stakeholders in the field of medicine i.e. manufacturer, trader and patient. The regulations therefore should be in favour of patient with the objective that quality medicines are produced for the benefit of the patient. India needs a better system of adverse drug reaction recording and strong pharmacovigilance system. There are problems at retail outlets also. The presence of pharmacists at the retail outlets should be non negotiable.
He recommended that licensing authorities should cancel the licence of the chemist if the pharmacy is being run without a pharmacist. Sale of medicines without a bill is also required to be strictly checked. Such sales lead to the introduction of spurious drugs in the sale chain. A prescription audit is one way to stop misuse of the drugs at the prescription level. There should be a visible robust system of recall of drugs reported as not of standard quality in the country. Inspection of manufacturing units is another area of concern. A uniform inspection methodology for inspection of manufacturing units to secure and protect the quality of drugs should be followed throughout the country.
The generic drugs produced in the country have made inroads in both developing and developed markets of the world. Indian pharma companies are of late being targeted in many importing countries. By raising barriers to protect the domestic industry, regulatory regimes are being tightened.
"Complaints have been received from the countries like Vietnam very recently in regard to the supply of drugs which were not of standard quality. It becomes the responsibility of the Indian regulatory authorities to ensure that position of Indian pharma industry is not compromised in the International market. The objective is to account for what goes out of India," he concluded.
The Drugs Consultative Committee is an important forum for bringing harmony in exercising regulatory control under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder.