Table 1 Recommendations to the DRAP and drug regulatory agencies in various low- and middle-income countries

• 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’