Pharmaceutical Regulatory: Regulatory Guidelines in Pharmaceutical Industry

Pharmaceutical Industry is one the industry which is highly regulated by stringent guidelines. The industry deals directly with public health, so it is man…

Pharmaceutical Industry is one the industry which is highly regulated by stringent guidelines. The industry deals directly with public health, so it is mandatory for the government to impose certain regulatory guidelines. In India a well-defined Drugs and Cosmetics Act 1940 is established to control the regulatory guidelines of Pharmaceutical Industry. Rapid growth of Pharmaceutical Industry has revamped and modernized the regulatory set-up of the country. Many areas including the production and distribution of healthcare products are brought under the same ambit of regulatory framework. Bio products, food additives and medical devices are all been regulated by regulating committee.

Conducive environment in India also encourages substantial growth in all departments. With the introduction of Patent Act 2005, many new manufacturers are able to patent their products and market them effectively.

The new regulatory guidelines have facilitated R&D activities to ensure the standard and quality of new drugs. It has also given an opportunity for the new players to invest in the emerging market of drugs manufacturing. Market friendly changes in the policies have also boosted up the market of Pharmaceutical Industry.

The prime objective of Regulatory authorities is to ensure the safety and quality of drugs. The regulatory guidelines ensure the standard of new drugs. It has been observed that an unsafe medicine can cause severe damage to the patient. Though utmost care is taken by R&D department before approval and introduction of the drug, still many tragedies do occur. The risk involved in such cases is liable to regulatory agencies. Thus it is important for the government to make sure that all pharmaceutical companies abide the regulatory guidelines stated under the Drug Act .It is also mandatory for the government to create a robust regulating system to ensure the quality and safety of drugs for the use of human and animals.