Generic Drug Regulations India
When a pharmaceutical company produces a drug, it files for a copy right patent to the regulation authority. In United Sates, Food and Drug Administration is responsible for all the regulation, testing, examination, and approval of drugs. Once approved, the drug is assigned three names: a chemical name, a generic name, and a brand name. The generic names are assigned by the Adopted Names Council of United States, while brand names are suggested by the manufactures and approved by the FDA. The manufacturer can also file a patent for the brand name to get the copy rights. The regulation of a drug and the nomenclature is a long process which is carried out after careful analyses and examination. No drug is approved until it meets all the requirements of the regulatory authority.
Generic Drug Regulation in India
In India, the drugs are regulated under the Drugs and Cosmetics Act 1940. The act had been amended time and again as the years passed by. There are two different organizations involved in the drug regulation: the Drug Controller General of India and the Controller General of Patents.
Drug Controller General of India (DCGI)
This organization approves the drug after analyzing and examining its quality, safety, and effectiveness. DCGI is an agency which is operated by the ministry of health.
Controller General of Patents
This agency deals with the designs trademarks of drugs and its main responsibility is to assign Patents. Controller General of Patents is an agency which works under the ministry of Commerce.
The Role of Central government
The Central Government keeps an eye on the whole regulatory process. It is also responsible for making amendments in the regulatory acts if required. The Central Government devises the regulation for the manufacturing of drugs, cosmetics, diagnostic devices, registration and authorization of foreign pharmaceutical companies to import drugs, authorization of local manufacturers to market the drugs, evaluation and examination of drugs for safety purposes, regulations of blood banks, vaccines, and many others.
The Delhi High Court dispute
More recently, a petition has been filed by Bayer, a multinational pharmaceutical company, in which they have requested the court to ask DCGI and the Controller General of Patents to work collectively for the regulation of drugs. The dispute was raised when DCGI authorized Cipla, another big pharma of India, to market their anti-cancer drug which was similar to the Bayer’s. Bayer’s requested the court that such an authorization will encourage duplicity of drugs and would lower their market value significantly. The court made a decision in favor of Bayer and announced a statement according to which no drug can be granted a marketing authorization if its counter part, similar drug is already patented. The order was strongly criticized by pharmaceuticals as it disabled the process of patenting generic drugs before the patent of brand-name drug expires.
Third-Largest Generic Drug Producer
For example, the regulations require drug companies to maintain a written statement of production and quality control procedures, document that the procedures are being followed and justify any deviation in writing. … has been under intense pressure to boost productivity amid an internal debate about possibly moving production from Morgantown to India to cut costs.
Generic Drug Delay
The issue sparked discussion at the last TRIPS Council meeting on 3 March, when the EU assured countries that the seizure of the generic hypertension drug Losartan (in transit from India to Brazil) in December 2008 in the Netherlands was an … The statement adds that the actions fit into a larger EU pattern of promoting so-called TRIPS-plus regulations (stronger than the TRIPS agreement) by supporting actions considered to be TRIPS.
Government regulation of drug
The prices were lower with these "mom and pop" boticas which were wiped out by big drug conglomerates Mercury, Commodore. Still, the prices are more affordable than in the U.S. and generic medication more accessible. … Even if the numbers are correct (ie, only 1/5 of price in India), those are prices there, not here. When those cheap medicines are imported into the Phils, there a fef re several costs to include.
Mail this post
