The regulatory issues in the Indian pharmaceutical industry are of prime importance. Understanding the regulatory scenario in this sector is extremely important for not only because of the rapid and ongoing changes at the globally and strong emphasis on good manufacturing practices (GMP), good clinical practices (GCP) and good laboratory practices (GLP) but also because responsibility on the regulatory bodies to ascertain a healthy supply of drugs at economical prices to the consumers.
A Drug is a specific substance recognized and located by an official Pharmacopeia and Formulary and used for rehabilitating, recognize, treatment and prevention of any kind of disease or disorder. Therefore, Regulation of Drugs and medicine is very much important keeping the public safety and health on primacy and is done by checking and scrutinizing the quality, efficiency and safety of drugs.
Biophar is a top pharma franchise company which vocalizes that medicine should be manufactured, prepared, stored and distributed under certain rules and regulations. So as to facilitate quality manufacturing organizations like Food and Drug Administration (FDA) has forbidden illegal and unethical manufacturing practices of drugs and medicines. The regulation of medicines is a very important and continuous process that needs to be followed. Certain factors like use of raw material, authentic formulas application, batch number maintenance, timely temperature check , humidity and light control, storage of medicine in appropriate packs, storage under standard conditions, adhering to procedures in the right manner, use of legal documents for maintaining the batch numbers, are some of the important conditions that are must for regulation of drugs.
The third-party manufacturing further adds that national governments are responsible for establishing strong national medicines regulatory authorities with clear vision, solid legal basis, practical objectives, appropriate organizational structure, and an ample number of qualified staff, sustainable financing, and access to latest technical literature, equipment and information for regulation of drugs. These authorities on regular basis confirm and check the working of quality control department of manufacturers and distributors for using technical literature and information in right direction.
To foster the same strict regulatory plans, implementation and legal documentation are made. The compliance of these regulatory guidelines will have quality manufacturing.
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