• Implementation of bioequivalence regulations to ensure the bioavailability and therapeutic efficacy of generics are at par with the innovator’s product |
• Ensure compendial monograph compliance to all active (APIs) and inactive ingredients (excipients), and formulated products, where applicable |
• Implement SUPAC (scale-up and post-approval changes) regulations to ensure that adequate regulatory controls are in place to assess the biopharmaceutic impact of post-approval changes in the product, its formulation, or changes in raw material or their suppliers, equipment or manufacturing processes, or facilities, etc. |
• Special consideration for potent drugs, psychoactive substances, cytotoxic drugs, etc. |
• Exceptional consideration for modified release or specially formulated products (e.g., ER, XR, CR, SR, DR etc.) |
• Special considerations for biological drugs and implementation of biosimilars/biobetters regulations |
• Allowance for consumer products (GSL and OTC products), polypills, etc. |
• Considerations for medical devices, such as inhalers |
• Pricing caps for generics to ensure that they are not registered above the registered price of an innovator’s brand if already available in the country |
• Enforcing regulations that all prescription drugs are ONLY dispensed on the prescription of registered medical practitioner and must be dispensed by a licensed pharmacist |
• Ensure that all drug stores in the country operate under the direct supervision and presence of registered pharmacists |
• Encourage ethical prescribing by enforcing antibribery regulations and subjecting prescribers to ‘fitness to practice’ and ‘code of conduct’ investigations on report or suspicion of a conflict of interest |
• Ethics, regulatory compliance, and good governance are the key to have ‘better generics’ for a ‘better tomorrow’ |