India’s Bulk Drug Capital, Yet Quality Hinges on One Overloaded Lab

Pharmacy
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Despite being called the “bulk drug capital,” Telangana relies on just one testing lab in Hyderabad to oversee drug quality for nearly 40% of India’s pharmaceutical output. In 2024, that lab tested 4,037 samples and flagged 130 as non-standard quality (NSQ). By July 2025, testing had dropped to 3,162 samples, with 55 deemed substandard far below the 12,000-sample annual target.

Why it matters:

Even now, samples take up to two months for testing delaying critical recalls. Spurious drugs from other states slip in before they’re even caught.

What authorities are doing:

The government has announced plans for four new regional labs in Warangal, Nizamabad, Mahabubnagar, and Nalgonda, along with hiring more drug inspectors to speed up sampling and testing.

Additionally, the Drug Control Administration (DCA) has ramped up enforcement: in just 19 months (Jan 2024–July 2025), over 42,000 inspections were conducted, 7,200 samples tested, and around 700 legal actions filed against violators.

This amused me led me thinking

  • Telangana is at a regulatory tipping point. Will it address the quality-control gap or continue risking patient safety?

  • Can a single lab keep pace with India’s pharmaceutical ambition?

  • Will decentralized testing become the norm before it’s too late?

  • Should clinical pharmacists amplify their voice in demand for better QC, not just rely on manufacturing claims?

What are your thoughts on this ?

MBH/AB

3 Likes
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It is an eye-opening issue, that Telangana, responsible for nearly 40% of India’s bulk drug production, relies on a single lab in Hyderabad for quality checks. In 2024, it tested just over 4,000 samples (target was 12,000), leading to delays of almost two months before unsafe drugs can be recalled. It’s great that new labs are being planned, but until they’re functional, this imbalance could impact medicine safety.

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I haven’t know before that Telangana is india bulk drug captial ,learnt alot of information.

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Telangana’s single lab can’t keep up with its massive pharma output. Delays in testing risk patient safety. Decentralized labs are a smart move, but action must be fast. Clinical pharmacists should speak up for stricter quality control. it’s about patient trust, not just company claims.

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The stress of one lab will surely be reduced, in future there should be more value added towards including of adding of new labs