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Drug regulators are gearing up to offset challenges as pharma procurement and supply chain turn more complex, according to Dr Sharad Mankumare, director, Reference Standards Laboratory, USP India.
The counterfeit drug market is growing rapidly, however, in the absence of a single international regulatory body, the pharmaceutical industry is finding it difficult to curb the counterfeiting menace. Globalisation has made the pharmaceutical industry procurement and supply chain more complex than ever before. Drug regulators caught between conflicting societal expectations and demands, he added.
Therefore role of regulatory agencies is to ensure appropriate licensing to manufacture, import, export, and distribution of medicines. The future challenges of medicine regulations are to ensure that access to innovative drugs with extensive premarket evaluation to reduce uncertainty is readily available. With both cost of development and regulatory assessment which is increasing, it now calls for the need for harmonization at international, regional and sub-regional level, he said
In fact, around 80 years ago, the evolution of regulations was triggered by some unfortunate events. These include the Diethylene glycol poisoning in the US in 1937. This saw the introduction of Food, Drug and Cosmetic Act in 1938 supported by US Congress. In 1960, the Thalidomide disaster saw the whole regulatory system being reshaped in the UK where a Committee on the Safety of Drugs (CSD) was formed in 1963.
Effective medicines regulation promotes and protects public health by ensuring its quality, safety and efficacy. The regulations ensure pharmaceuticals are manufactured, stored, distributed and dispensed in as per the norms of the global and national regulatory authorities. Fair promotion and advertising of medicines also ensure rational use of drugs.
The key role of the regulatory authority is to assessing the safety, efficacy and quality of medicines, and issuing marketing authorisation for individual products. The enforcement officials also need to keep a surveillance of manufacturers, importers, wholesalers and dispensers of medicine. Their key task is to control and monitor the quality of medicines in the market, said Dr Mankumare in a presentation on the ‘Present and future scenario of regulatory guidelines’ at the recently concluded Indian Pharmaceutical Congress in Mysuru.
Further, the regulators will need to control the excessive promotion and advertising of medicines to avoid irrational use. They also need to keep a close watch on the safety of marketed medicines including collecting and analyzing adverse reaction reports. In addition, the regulators also have the responsibility to provide independent information on medicines to professionals and to the public. Therefore, drug regulators need to gear up to offset challenges as pharma procurement and supply chain are becoming more complex, he said.
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