Abstract: In order to assess the quality, safety and efficacy of a product, drug regulators of all countries require the manufacturer to provide all relevant data and other information before according approval. The data for new drugs include, among others, data collected through pre-clinical and clinical trials submitted to the drug regulatory agency for approval. On the other hand, for generics, the applicants need to show the product for which approval is sought is equivalent to the one already being marketed. The pharmaceutical market is thus regulated through two sets of rules - those relating to the intellectual property (IP) and regulatory requirement mandated by the drug control authority. Both these have different objectives and are administered by different government agencies. IP rights are meant to recognize and reward innovation by providing inventors with temporary monopoly rights. The drug regulatory system, or registration system ensures that only medicines of assured safety, quality and efficacy are available in the national market as medicines that are ineffective or of poor quality can not be efficacious but could well be dangerous for the patients.
The issue currently being debated in India relates to whether test data submitted to the drug regulatory authority (the Drug Controller-General of India) by the applicant company (patent holder or licensee) for market authorization for the product to third party needs to be 'protected' in India. There is no such protection available in India now. The original registrant companies generally MNCs claim that significant money is invested in clinical trials for generation of such test data and therefore any exploitation by generic manufacturers without adequate compensation is unfair exploitation These companies therefore want 'data protection', a system of non-disclosure of trial data to third party by the Drug Regulator for a certain specified period. Through such a protection, companies are ensured of extended monopoly for their product beyond the 20 year patent life. |
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