Abstract
The CDSCO prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, diagnostics, cosmetics and devices in the country. Pharmaceutical research and development is an expensive, time consuming and uncertain process that may take 8-10 years to complete. Patent clock starts much before a new drug is approved for marketing and significant amount of time may be lost in the review and approval process by regulatory bodies. So in order to recoup the considerable time and resources invested in the drug development and approval process, the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies. Patent strategy provides a check list for developing comprehensive patent strategies for the company.
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