India’s booming biopharma sector presents a new challenge for regulators.
Biopharmaceuticals are taking over chemical drugs in the medical race to save lives. They’re a burgeoning business in India, a multi-billion-dollar market growing at an annual rate of 19 percent.
The products include insulin, vaccines, blood products such as albumin, hormones, and monoclonal antibodies used as anti-cancer agents – medicines that treat life-threatening diseases. But unlike chemical-based drugs, they are often highly temperature sensitive and vulnerable to degradation, depending on how and where they are made, transported or stored.
Biopharmaceuticals require special attention to ensure their quality throughout their life cycle from production to expiry and disposal. A recent study of 17,451 batches of samples assessed over a decade (2011–21) found 2.34 percent were of poor quality. Even though this is less than for chemical drugs, what is worrying is the category they belong to, which includes medicines used to treat life-threatening conditions such as cancer, heart attack, haemophilia and serious injuries or burns, and even extended to in vitro diagnostic kits used to detect HIV and hepatitis antibodies.
The compromised quality of drugs like these poses a serious threat to the health of patients – and India’s overall health infrastructure.
Evaluating biopharmaceuticals for their quality is more complex than for chemical drugs, creating a challenge for regulators. Today, regulators primarily assess biopharmaceuticals in four ways: assessment of documents, site inspections, quality-control testing by National Control Laboratories, and post-marketing checks as and when required.
Guidelines and regulations are already in place with regard to pre-marketing (pre-clinical, clinical) and post-marketing requirements, and for the manufacturing process and quality control, but equally robust infrastructure for implementation and checkpoints is required.
As India’s biotech sector booms, regulators need to strengthen the checks at the beginning of the process to avoid being a bottleneck later as the number of biopharmaceuticals they need to license grows. Otherwise, it will be akin to having the required curriculum and schools, but not enough teachers to cater for students or monitor their progress.
Given the current number of National Control Laboratories catering to quality evaluation of biologicals, many products are currently being released only on the basis of dossier reviews and on-site inspections.
NCLs are also tasked with testing confiscated or fake drugs as and when they are found by drug inspectors. Several rackets focused on manufacturing fake, spurious or substandard drugs have been identified and busted by regulatory authorities already. The consequences of such poor-quality drugs being administered to the needy are not difficult to comprehend and such incidents highlight the gravity of crime related to health practices in the country.
India does undertake drug surveys to assess the number and causes of substandard medicines, but the same surveys are not feasible for biopharmaceuticals because of the drugs’ high cost, their temperature sensitivity during transport and storage, and the absence of state-of-the-art national laboratories for complete testing of such complex molecules. If quality checks are made available even at pre-release stages such as production, or during clinical trials or other relevant checkpoints to evaluate progress or quality, it could save time and money in conducting surveys after release and weeding out substandard products even before their final release.
The time taken for regulatory approvals, particularly of life-saving drugs, is equally important. To ensure safety along with speed, more state-of-the-art laboratories are needed to evaluate the ever-increasing biopharmaceuticals and their equally in-demand cousins, biosimilars. These laboratories could be made aware of new biopharmaceuticals awaiting approval from licensing authorities so they’re ready to test, saving time in granting approvals.
Healthcare policymakers should consider these bottlenecks and devise suitable policies to strengthen the regulatory infrastructure in order to keep substandard drugs from being produced or reaching the market.
Rashmi Shrivastava is currently working as a scientist at the National Institute of Biologicals and has over 20 years of experience in the field of life science.