{"id":45196,"date":"2025-12-29T11:32:39","date_gmt":"2025-12-29T06:02:39","guid":{"rendered":"https:\/\/dailynewsindia.co.in\/index.php\/2025\/12\/29\/ayush-drug-quality-regulation-10-bold-safeguards-implemented\/"},"modified":"2025-12-29T11:32:39","modified_gmt":"2025-12-29T06:02:39","slug":"ayush-drug-quality-regulation-10-bold-safeguards-implemented","status":"publish","type":"post","link":"https:\/\/dailynewsindia.co.in\/index.php\/2025\/12\/29\/ayush-drug-quality-regulation-10-bold-safeguards-implemented\/","title":{"rendered":"AYUSH Drug Quality Regulation: 10 Bold Safeguards Implemented"},"content":{"rendered":"
\n

New Delhi [India], December 29:<\/b> AYUSH medicines don\u2019t float in regulatory limbo. They operate under a dense, rule-heavy system that most critics never bother to read. Here\u2019s what actually keeps Ayurveda, Siddha, Unani and Homoeopathy drugs in check.<\/span><\/p>\n

\n

India\u2019s AYUSH sector sits at an awkward crossroads. Hugely popular. Deeply traditional. Constantly questioned. What rarely gets attention is the regulatory scaffolding holding it together. It exists. It\u2019s detailed. And it\u2019s far from symbolic.<\/span><\/p>\n<\/blockquote>\n

At the centre of this system is AYUSH drug quality regulation, a framework built on testing, surveillance, certification and enforcement. Let\u2019s break it down without the fog.<\/span><\/p>\n

PCIM&H and the Backbone of AYUSH Drug Quality Regulation<\/b><\/h2>\n

The Pharmacopoeia Commission for Indian Medicine and Homoeopathy, or PCIM&H, operates under the Ministry of Ayush. Its role is blunt and non-negotiable. It acts as the appellate drug testing laboratory for Ayurveda, Siddha, Unani and Homoeopathy drugs.<\/span><\/p>\n

That means when quality disputes arise, PCIM&H is the final word on identity, purity, strength and composition. No opinions. Just lab results.<\/span><\/p>\n

PCIM&H also publishes pharmacopoeial standards and formularies. These documents are not academic fluff. Under the Drugs and Cosmetics Act, 1940, compliance with these standards is mandatory for manufacturers. Miss them, and you are in violation of the law.<\/span><\/p>\n

Drug Testing Laboratories and Rule 160 A to J<\/b><\/h2>\n

AYUSH drug quality regulation is anchored in Rule 160 A to J of the Drugs Rules, 1945. These rules govern how drug testing laboratories are approved to test Ayurvedic, Siddha and Unani medicines.<\/span><\/p>\n

\n

As of today, 34 State Drug Testing Laboratories have received central support to upgrade infrastructure and functionality. Beyond that, 108 laboratories are officially approved or licensed to test AYUSH drugs and raw materials.<\/span><\/p>\n<\/blockquote>\n

Add to this three Regional Research Institutions under the Central Council for Research in Ayurvedic Sciences, approved under Rule 160E. These labs aren\u2019t decorative. They are legally empowered testing bodies.<\/span><\/p>\n

Pharmacovigilance for AYUSH Drugs Isn\u2019t Optional<\/b><\/h2>\n

AYUSH drug quality regulation doesn\u2019t stop at manufacturing. It extends into the market.<\/span><\/p>\n

Under the Central Sector Scheme Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana, or AOGUSY, India runs a nationwide pharmacovigilance programme for AYUSH drugs.<\/span><\/p>\n

The structure is three-tiered:<\/span><\/p>\n