CDSCO calls for crackdown on Buclizine sales; Mankind Pharma taken to court: Report

Those found manufacturing, selling or distributing buclizine on or after December 13 without adhering to the orders given by CDSCO, will be liable for punishment under India’s drug regulations. This includes imprisonment for up to three years and a fine of up to Rs 5,000.

New Delhi: Cracking down on the illegal sale of Buclizine- an apeitite stimulant, the apex body CDSCO has now written to its state counterpart, asking them to keep a strong vigial as welll as punish those who are indulging in the practice

Popularly sold by Mankind Pharma, anti-histamine Buclizine was recently under the scanner for not undergoing clinical trials to test its efficacy and safety. The drug is likely to be mired in controversy again. According to a recent media report, the Central Drugs Standard Control Organisation (CDSCO) has issued an advisory to state drug regulators directing them to “keep a strong vigil” on the manufacture, sale and distribution of a brand of buclizine.

Anti-histamine in nature, Buclizine is used to treat patients suffering motion sickness especially with the symptoms of gastric pain, dizziness, nausea, vomiting and headaches.

Medical Dialogues had earlier reported that through a recent gazetted notification, the Union Health Ministry had prohibited the distribution and sale of anti-histamine drug Buclizine as an appetite stimulant “in public interest” under the Drugs and Cosmetics Act as the Central Government was satisfied that the use of said drug Buclizine does not have any therapeutic value claimed for as an appetite stimulant and is likely to involve risk to human beings.

The drug was, however, allowed to be marketed for “symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness.”

Also Read: Mankind Pharma faces setback: Government prohibits Buclizine as Apetite Stimulant

Despite the Government’s prohibitory orders, the drug is sold as an appetite stimulant. It has been reported that numerous batches of the medicine continue to be sold without mandated disclaimers, bypassing Government order to mention “in conspicuous manner” on the drug’s package insert and promotional literature that it was “not to be used as appetite stimulant”.

This triggered public health activist Dinesh Thakur to approach the Delhi High Court last week urging that the Government be directed to initiate “criminal proceedings” against Mankind Pharma and its “agents” for not recalling Longifene batches manufactured before December 2018, which did not carry the labels.

Thakur's plea adds that the Government has not even furnished a copy of the report or findings of an expert committee constituted in March 2013 to “investigate” the manner in which the approval for buclizine as an appetite stimulant was given.

The application is part of his ongoing lawsuit to ban certain medicines sold in India despite Government experts having red-flagged them for safety issues since 2012, reports The Indian Express.

In a stringent view of the matter, the Drug Controller General of India Eswara Reddy in a fresh advisory by the CDSCO informs about the irregularity.

“It has been brought to the notice of this office that Longifene … tablets and syrups continue to be sold in pharmacies without complying with the above labelling requirements,” reads the issued advisory.

“In view of the above, you are requested to direct your inspectorate officials to keep a strong vigil on manufacture, sale and distribution of buclizine and its formulations for use in human beings and in case of contravention of any provision of the said Act (Drugs and Cosmetics Act, 1940) and Rules made thereunder, and take necessary action to ensure that the drug is manufactured, sold and distributed strictly in accordance with the provisions of the said Act and Rules,” the advisory added.

According to The Indian Express, CDSCO has also directed its own zonal and sub-zonal offices to “take similar action” in coordination with state licencing authorities.

It is further reported that those found manufacturing, selling or distributing buclizine on or after December 13 without adhering to the government’s orders is liable for punishment under India’s drug regulations. This includes imprisonment for up to three years and a fine of up to Rs 5,000.

As per a report by the daily, a private investigator’s survey of over 170 pharmacies in Delhi, Gurgaon and Hyderabad showed that Longifene, Mankind Pharma’s buclizine brand, continues to be sold for appetite stimulation without the required label.

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