Outsourcing Drug Factory Inspections Is a Risk India Cannot Afford

 

                                                                                                                           - Ganadhish Kamat

India’s pharmaceutical industry proudly calls itself the “pharmacy of the world.” From antiretroviral medicines to affordable generics, the country supplies drugs to more than 200 nations. Yet this reputation ultimately rests on one crucial pillar: the credibility of India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO). Recent proposals to allow third-party agencies to conduct Good Manufacturing Practice (GMP) inspections, potentially through accreditation mechanisms involving the Quality Council of India undermines that credibility. The rationale is understandable. India has thousands of pharmaceutical manufacturing facilities but an acute shortage of trained inspectors. Outsourcing inspections appears to be a practical way to expand oversight capacity quickly. However, delegating such a core regulatory responsibility carries risks that could ultimately weaken India’s regulatory oversight rather than strengthen it.

Inspections Are Not Just Audits

A GMP inspection is far more than a checklist exercise. Inspectors assess whether manufacturers follow stringent quality systems governing everything from raw material sourcing to batch documentation and contamination control. They must exercise judgement, interpret regulations, and sometimes take enforcement action. In other words, inspections are not merely technical audits, they are sovereign regulatory functions. When deficiencies are identified, the authority to issue warnings, suspend licenses, or initiate legal action rests with the regulator. Outsourcing the inspection itself risks blurring this chain of accountability.

The Problem of Conflicts of Interest

The most obvious concern with third-party inspections is the potential for conflict of interest. External auditors typically operate on a fee-for-service model. Some pharmaceutical companies may be engaging the same agencies who are engaged by CDSCO for internal audits or other assignments by paying for such services. The independence of such agencies in carrying out regulatory inspection is questionable. Global regulators have long avoided this arrangement precisely for this reason. When public health is at stake, regulatory oversight must remain clearly independent from commercial relationships.

The Risk of Diluting Standards

Allowing multiple third-party bodies to conduct inspections could create variability in how GMP standards are interpreted and enforced. Even within tightly coordinated regulatory networks such as Europe’s, achieving consistency across inspectorates requires extensive training and harmonisation. India’s regulatory system already involves both central and state authorities. Adding another layer of external auditors may complicate the regulatory landscape further, increasing the risk of inconsistent outcomes.

Confidentiality and Trust

Inspections provide access to highly sensitive information: manufacturing processes, proprietary formulations, and quality systems. When such access is extended beyond government authorities to multiple external agencies, concerns about data security and confidentiality inevitably arise.

What Leading Regulators Do

The U.S. Food and Drug Administration conducts inspections through its own trained investigators who are empowered to issue form FDA 483 at the end of inspection, listing the violations observed during inspection. The compliance branch then classifies the inspection based on the nature of violations and response received from the manufacturer and can take enforcement actions such as  issuing warning letters, impose import alerts, or halt production if necessary.

In Europe, inspections are coordinated by the European Medicines Agency but carried out by government inspectorates in individual member states. These authorities operate within a harmonised framework and share inspection findings across the European Union.

Similarly, drug regulatory agencies of other countries such as Japan’s PMDA, UK's MHRA, Australia's TGA, South Africa's MCC, Mexico's COFEPRIS etc all rely on their own regulatory inspectors to ensure compliance.

The pattern across advanced regulatory systems is clear: governments retain direct control over GMP inspections. Collaboration between regulators is common, but outsourcing to private auditors is not.

Lack of pro-active action by CDSCO

A strong regulatory system depends on institutional knowledge accumulated through years of inspections, investigations, and enforcement actions. Once that capacity erodes, rebuilding it becomes difficult. When CDSCO started their Risk-based inspection program in 2022, it was evident that they had capacity for conducting approximately 400 inspections per year. The total number of manufacturing sites in India is also known. With this information in hand, and knowing that revised Schedule M is going to be implemented soon, CDSCO could have taken proactive measures in last 3 years to recruit adequate number of inspectors to carry out inspections in reasonable period of time.  

The Real Solution

India’s inspection challenges are real, but outsourcing is not the solution. A more sustainable strategy would involve expanding and professionalising the inspection workforce within the Central Drugs Standard Control Organisation and the state drug authorities, and adopting risk-based inspection models that focus resources on higher-risk facilities and products. External experts/agencies can be used to train the newly hired inspectors.  Changes in law are also required to bring state drug regulatory agency directly under the Central drug control organization so that all the resources are consolidated and better utilized. The centralization will also ensure higher accountability of all drug inspectors and other drug regulators in the states.  

India can also deepen international regulatory cooperation—sharing inspection findings and collaborating with trusted regulators abroad. Such reliance mechanisms are increasingly common globally and allow regulators to conserve resources without compromising independence.

Credibility Is Hard Won

India’s pharmaceutical sector is too important to risk regulatory shortcuts. The global trust that Indian medicines enjoy today was built over decades of compliance with stringent international standards. Outsourcing GMP inspections may appear to offer a quick fix to staffing shortages. But when it comes to safeguarding drug quality and India’s reputation as the pharmacy of the world regulatory credibility must remain firmly in government hands.