look news india
The Central Government’s Central Drugs Standard Control Organization (CDSCO) and the Union Health Ministry have taken a historic step to bring the quality, safety and efficacy of medicines in the country at par with global standards. The government has issued a new draft notification (GSR 955(E)) of amendment to the Drugs Rules, 1945 and has proposed that now pharmaceutical companies will have to compulsorily appoint authorized qualified personnel for the release of each of their drug batches. After the implementation of the new rules, the entire lot of any medicine will not be sent for sale or distribution in the market unless a qualified technical officer authorized by the company gives his seal and written approval on the Batch Release Certificate of the medicine. The main objective of this step is to strengthen the quality control in the Indian pharmaceutical industry, completely crack down on the manufacturing of counterfeit or substandard drugs and enhance the credibility of Indian pharma brands at the international level.
Under the new proposal introduced by the Ministry of Health and Family Welfare, the accountability of processes related to manufacturing and distribution of medicines has been significantly tightened. According to the changes being made in the Drugs and Cosmetics Rules (Drugs Rules, 1945), now every manufacturing company will have to follow a prescribed format for issuing batch release certificate. This process of batch release is considered to be the most delicate stage of drug manufacturing. Under this, all the parameters of manufacturing material, lab testing report, stability, packaging and quality of the medicine will be thoroughly reviewed. If any one parameter of quality does not meet the standards, the authorized officer will have the legal right to stop the approval of that batch.
The draft of the new rules also clarifies who can be the authorized person to test and approve batches in pharmaceutical companies. The Central Government has banned arbitrary selection and made it mandatory that only a person can become this officer who has a medical degree from a recognized university with specialization in Pharmacy (B.Pharm/M.Pharm), Pharmaceutical Chemistry or Clinical Pharmacology/Microbiology. Along with this, the person will also be required to have a minimum of years of practical experience in drug manufacturing and laboratory testing. This will end the arbitrariness of the top management of the companies and only fully competent and responsible scientists will be able to decide the supply of every medicine in the market.
Under the draft notification, it will now be mandatory for drug manufacturing companies to keep the batch manufacturing records (BMR) and testing records of every medicine manufactured in digital and physical form safe for a long time. If in future any batch of medicine causes side effects to any patient or any question arises about its quality, the investigating agencies will be able to immediately scrutinize the complete records of that batch. It should be clearly recorded in the records from where the ingredients of the medicine were purchased, at what temperature the medicine was prepared and which technical expert gave it the green signal. This arrangement will completely eliminate the scope for data manipulation or back-dated entries, thereby ensuring strict compliance with Good Manufacturing Practice (GMP).
India is called the ‘Pharmacy of the World’ and from here generic medicines and vaccines are exported on a large scale to more than 200 countries of the world. However, in recent years, questions have been raised repeatedly about the quality of Indian medicines in international forums. With this regulatory amendment, the ‘Qualified Person’ (QP) model will be implemented in India on the lines of the stringent rules of America’s US-FDA and Europe’s EMA (European Medicines Agency). The Union Health Ministry believes that this strict system will not only provide completely safe and standard medicines to the domestic patients of India, but will also provide a new and strong foundation to the credibility of the Indian pharmaceutical sector in the international export market.
The Health Ministry has published this draft notification (Draft Amendment Rules) in the Gazette and has sought suggestions and objections from all major pharma organizations, drug manufacturers, experts and the general public within 30 days. After reviewing the suggestions received, the Central Drugs Standard Control Organization (CDSCO) will finalize these rules and implement them across the country. Excise and drug inspectors will also be given special powers to conduct surprise inspections of companies on the basis of these rules.