Can a centralized regulation help drug quality?

What is the current regulatory landscape?

The Central Drugs Standard Control Organization (CDSCO), which has zonal and sub-zonal offices and labs across the country, is the apex regulatory body. It is responsible for approving new drugs, import of drugs and devices, clinical trials and laying down standards for drugs. Each state has its own regulator as well, which is often conjoined with the food and drug administration in the state. The state regulators look after licensing and auditing manufacturing facilities, and distribution and sale of drugs. They also grant licence for manufacturing drugs that have been around for 4 years or more.

What is the new proposal?

The fine print of the proposal is not out, but it’s likely a step toward centralization of drug regulation in India. Currently, drugs older than four years can be registered in one state and sold in another. The health ministry may be planning a single centralized system for the registration of all kinds of drugs, under the CDSCO. There is already an online CDSCO repository called Sugam, which maintains a database of both approved and under-approval drugs. If all registration were to happen in one place, it will be easier to maintain a Sugam-like registry and use it for quality checks.

Will it have a bearing on export quality?

Not much, as drugs sold in the global market are subject to regulations of the buyer country. The US and Europe deploy vast resources to make pharmas adhere to their own standards. Poorer countries such as Gambia often rely on a list of manufacturers and inputs of the World Health Organization (WHO). A centralized repository can aid in better monitoring.

Will it help improve drug quality?

Even if drug registration is centralized, the regulation for manufacturing will continue to be decentralized. A plant is jointly inspected by the CDSCO and state regulators at the time of licensing of drugs, but regular auditing is usually done by state regulators. Lower-level bureaucrats and inspecting officials need capacity-raising and training. India needs greater accountability at the manufacturer level to adhere to norms. Centralization may be a step in the right direction—it will not be enough.

What else can be done to improve standards?

Along with tighter regulation of manufacturing, there is a need for a national policy on recall of drugs. If a drug is found to be substandard or spurious in one state and recalled by the regulator there, it is not necessarily recalled in other states.It should be the job of the national regulator to ensure that a defective batch isn’t sold in other markets. Last, the track record of prosecuting and penalizing drug manufacturers for violating norms is poor in India.