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DoP withdraws order on Wilson's disease drug, pencillamine, as production & supply improves

Ramesh Shankar, Mumbai
Monday, July 17, 2017, 08:00 Hrs  [IST]

Even as the production and supply of Wilson's disease drug pencillamine has improved considerably in the country, the Department of Pharmaceuticals (DoP) has withdrawn its directives to the manufacturers to resume normal production and distribution of this life-saving medicine in the country.

“I am directed to refer to this department's letters of even number dated 21 December, 2016 and dated 28 April, 2017 and to say that since the production/supply of the above said formulation has improved, the government has decided not to extend the above said orders”, said the DoP in its notice to the manufacturers Panacea Biotec, New Delhi; Samarth Life Sciences, Mumbai; VHB Life Sciences, Mumbai; Fleming Laboratories, Hyderabad; and Biophore Pharmaceuticals, Hyderabad.

Earlier last year, the country was facing a serious shortage of D-penicillamine, prescribed for Wilson’s disease, a rare and potentially fatal genetic disorder that causes excessive accumulation of copper in vital organs like the eyes, liver, kidneys and brain. The disease could even cause liver failure if left untreated, leaving the patient in need of a transplant.

Since the availability of the drug is very important as there are no alternatives for the treatment of Wilson’s disease in the country, Drugs Controller General of India (DCGI) Dr GN Singh convened a special meeting with the companies that produce this life-saving drug on September 30, 2016 to address the issue. In the meeting, the representatives of various firms mentioned that because of small number of patients who require penicillamine capsules in the country, the demand of the drug is low. It was also mentioned in the meeting that the availability of bulk drug was also an issue as the suppliers of the drug’s most crucial raw material were favouring other markets for better margins.

But, as all its persuasive measures failed to resolve the lingering issue of shortage of this drug, the DoP in December last year invoked emergency provisions of the DPCO (Section 3 (i) of DPCO, 2013) to give direction to the manufacturers to resume normal production and distribution of the drug. The decision to invoke emergency provisions of the DPCO to overcome the shortage of pencillamine was taken by the DoP after a review meeting held by secretary, DoP, on 6.12.2016 which was attended by chairman, NPPA and the DCGI, besides the representatives of manufacturers of formulations of D-Pencillamine Panacea Biotech and VHB Life Sciences.

 

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