India Pharma Outlook Team | Monday, 12 October 2026
India’s drug testing laboratories are facing renewed scrutiny over their capacity to deliver timely results as regulators weigh faster testing against the practical demands of pharmaceutical quality control.
The Drugs Consultative Committee (DCC), under the Union Health Ministry, has rejected proposals to shorten the statutory timeline for drug testing and to permit adjacent, separately licensed manufacturing facilities to share a common quality-control laboratory.
The decisions highlight operational challenges involving laboratory staffing, sample volumes and testing complexity.
They also bring attention to the need for stronger testing infrastructure and digital coordination as India expands its drug-quality monitoring efforts.
At its 70th meeting, the DCC considered a proposal from Himachal Pradesh to reduce the statutory drug- testing and reporting timeline from 60 days to either 15 days or one month.
However, the committee retained the existing 60-day timeline, citing practical constraints affecting government laboratories.
These challenges include:
The DCC also indicated that states could establish internal standard operating procedures to prioritize critical, life-saving or urgent public health samples according to their capacity.
This approach allows regulators to focus on time-sensitive cases without imposing a shorter statutory deadline across all samples.
Also Read: How Can India Pharma Bridge the Gap Between Innovation and Access
The DCC's decision comes amid efforts to expand India's drug-testing infrastructure.
According to a March 2026 update from the Ministry of Health and Family Welfare, the government released Rs 756 crore as its central share under the Strengthening of States’ Drug Regulatory System scheme.
The initiative has supported the construction of 19 new drug-testing laboratories and the upgradation of 28 existing laboratories across states and Union Territories.
These investments are intended to strengthen testing capacity and improve regulatory oversight. The need for this infrastructure is also reflected in rising sample volumes.
Government data show that state and Union Territory drug controllers tested 116,323 samples in 2024–25, compared with 84,874 in 2020–21.
The figures underline the growing workload handled by drug regulators. However, expanding laboratory capacity involves more than establishing facilities.
Adequate staffing, equipment, validated testing methods and access to reference standards remain important for timely and reliable results.
Alongside physical infrastructure, digitalization is emerging as another part of India's regulatory response.
Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi suggested that state and Union Territory drug controllers begin onboarding SUGAM Labs, an integrated CDSCO portal for managing regulatory enforcement, sampling, laboratory testing and post-marketing surveillance.
The platform is intended to support end-to-end digital management of regulatory workflows.
Greater adoption could improve coordination between regulators and laboratories, while reducing administrative delays associated with sample handling and information exchange.
The DCC also advised government laboratories to obtain analytical methods submitted during product approval through CDSCO headquarters or its authorized database rather than requesting them from manufacturers.
This measure could help address delays caused by difficulties in accessing testing methods.
However, digital coordination cannot independently resolve shortages of laboratory personnel or the time required for complex analytical procedures. Its effectiveness will depend on implementation across states and integration with laboratory operations.
Also Read: How to Apply for India's Rs 10,000 Crore Biopharma SHAKTI Scheme
The DCC's decisions highlight a broader regulatory challenge: strengthening drug-quality surveillance requires both adequate testing capacity and efficient administrative processes.
Government investment in laboratories, better access to analytical methods and digital platforms such as SUGAM Labs could help address different parts of this challenge.
For India's pharmaceutical sector, the immediate focus remains on ensuring that drug samples are tested reliably while urgent public-health cases receive appropriate priority.
Whether infrastructure expansion and digital adoption can improve testing turnaround times will depend on how effectively these measures address the operational constraints identified by regulators.
.jpg)
