CDSCO drug alert: Himachal pulls 92 substandard batches, halts 96 pharma units

State health authorities ask patients to stop using flagged batches as 70 drug samples produced in the state fail critical ingredient tests while 22 show minor defects.

New Delhi: The Himachal Pradesh Drugs Control Administration has asked patients and the public to stop using specific batches of medicines declared ‘not of standard quality’ (NSQ) by the central drug regulator, according to the two senior government officials familiar with the matter and documents reviewed by Mint.

The alert follows the Central Drugs Standard Control Organisation's (CDSCO) September 2026 report, which flagged 330 drug samples nationwide as sub-standard. Of these, 92 originated from Himachal Pradesh manufacturers.

State health authorities confirmed that 70 of the 92 failed critical efficacy parameters—specifically assay and dissolution tests—while 22 showed minor defects, such as labelling issues. To enforce compliance, the state has ordered 96 pharmaceutical facilities to halt manufacturing, either entirely or across specific sections, pending corrective actions. The state accounts for roughly a third of India's domestic drug supplies alongside large export volumes.

Himachal Pradesh is home to over 650 pharmaceutical manufacturing units, largely based in Baddi. About 70% of these are micro, small and medium enterprises (MSMEs) and 15-20% are large companies. The state accounts for about 35% of India's total domestic drug formulations, meaning every third drug on a chemist's shelf in India originates from Himachal Pradesh.

Widely prescribed medicines flagged

According to the CDSCO’s website, several widely prescribed medicines manufactured across Solan and Baddi in Himachal Pradesh were declared NSQ after failing critical active ingredient tests:

• Aspo Pharmaceuticals’ Namik-MR tablets, indicated for muscle pain or spasms failed in its aceclofenac content.
• Multiple respiratory formulations were also flagged, including Pharma Roots Healthcare’s AX Cold syrup, prescribed for allergic cough and congestion, which failed ambroxol hydrochloride levels.
• Similarly, Alventa Pharma’s Healtuss LS and Ultra Drugs Formulations’ Cufcott LS, both bronchodilator and expectorant syrups indicated for productive cough and asthma-related airway congestion, failed tests for ambroxol hydrochloride and levosalbutamol.
• Saar Biotech’s K-Coff-D syrup, used to treat dry cough, nasal blockage, and allergic cold symptoms, was cited for deficient phenylephrine hydrochloride content.
• In the topical analgesic category, Cent Cure’s Gone Gel, applied for joint pain, musculoskeletal aches, and sprains, failed the required standard for methyl salicylate.

State cites high volumes

“The volume of substandard samples must be evaluated in proportion to the state’s massive manufacturing output. Himachal Pradesh contributes to approximately one-third of domestic supplies, besides exporting big volumes of drug formulations,” Himachal Pradesh health secretary Ashish Singhmar said, pointing out that the state’s share of failed samples actually declined from 34% in July to 28% in September.

State drug controller Dr. Manish Kapoor said, “The drugs control administration, Himachal Pradesh, maintains a zero-tolerance approach towards the manufacture or distribution of substandard medicines and every effort is being made to ensure strict compliance of regulatory requirements. Following procedures laid down under the law, not only are the licences to manufacture drug formulations suspended/cancelled by the DCA HP, but at parallel, legal action(s) are also taken by the jurisdictions from where samples get drawn for the purpose of analysis/testing.”

“The enforcement is an ongoing administrative check-and-balance: these 96 actions particularly are not entirely on the latest NSQ list. It is an ongoing process where facilities are halted either due to NSQs or when other deficiencies are found during inspections. Increased detection is a positive indicator that our regulatory mechanism is strengthening," he added.

Dr. Kapoor also pointed out that drugs often degrade after leaving factories. "There are multiple stress factors in the distribution chain—storage conditions, temperature, humidity, and rough transport—that can cause quality failure. We cannot exclusively blame only manufacturers."

Queries sent to the health ministry and the Drugs Controller General of India on Tuesday remained unanswered at the time of publishing. Queries sent to Aspo Pharmaceuticals, Alventa Pharma, Ultra Drugs, also remained unanswered, while Pharma Roots Healthcare couldn't be contacted.

About the Author

Priyanka Sharma is a journalist at Mint, where she covers the Union Ministry of Health and the pharmaceutical industry. Her work focuses on explaining government policies and how they impact healthcare and the medicine market in India. With 12 years of experience in journalism, she has built a reputation for providing clear and honest news on important health topics that affect the entire country.<br><br>Her educational background includes a journalism degree from the prestigious Indian Institute of Mass Communication (IIMC) and specialized training in public health from the Public Health Foundation of India. Before her current role at Mint, Priyanka worked with India Today, The Pioneer, and ANI. She also served as a lead consultant for the National Health Authority, which gave her firsthand knowledge of how the government manages large-scale health programmes.<br><br>Priyanka is based in New Delhi and is an avid traveller who loves visiting the mountains. She has a great interest in regional flavours, particularly South Indian food.