Even as all its persuasive measures failed to resolve the lingering issue of shortage of Wilson's disease drug Pencillamine in the country, the Department of Pharmaceuticals (DoP) has now invoked emergency provisions of the DPCO to give direction to the manufacturers to resume normal production and distribution of this life-saving medicine in the country.

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.

After due deliberations on the current situation and alternatives available with the government to resume normal production and distribution of the medicine, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013 which provides as under: “The Government may-- (i) with a view to achieve adequate availability and to regulate the distribution of drugs in case of emergency or in circumstances of urgency or in case of noncommercial use in public interest direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase the production and to sell such active pharmaceutical ingredient or bulk drug to such other manufacturer(s) of formulations and to direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be," the DoP said.

Accordingly, the companies manufacturing the API of D-Pencillamine medicine in India Fleming Laboratories and Biophore Pharmaceuticals have been directed that these companies will report the annual production and sale of the said API in the last three financial years to NPP A and DCGI; these companies will report the production plan and capacity for next three months to NPPA and DCGI and will follow their directions for production of the said API and sale to the manufacturers of the formulations; these companies will give first right of refusal to buy the supply of said API to Panacea Biotech and second right of refusal to buy the supply to VHB Life Sciences before selling or marketing to the other manufacturers; during the period of three months, these companies will submit a weekly report of delivery of API and the plan of production of the next week to NPPA; and any proposal for sale of the said API besides these two companies referred to in point (iii) above will require written permission of NPPA during this period.

Likewise, the companies manufacturing the formulations of D-Pencillamine in India (Panacea Biotech and VHB Life Sciences) have been directed that these companies will report the quarterly production and sale of the said medicine in India during last financial year to NPPA and DCGI; these companies will report the production plan and capacity for next three months to NPPA and DCGI and will follow their directions for production of these medicines at the average level of the previous financial year; these companies will source their supply of API D-Pencillamine from Fleming Laboratories and Biophore Pharmaceuticals who are also being directed under the present order to supply the API; during the period of three months, these companies will submit a weekly report of delivery of API received, formulations produced and formulations distributed. They will also submit a weekly production plan for the next week to NPPA and DCGI; they will also submit a weekly report about the efforts made to reach out to the patients and hospitals for ensuring accessibility to the medicine; these companies will simultaneously make effort to tie up the supply of D-Pcncillamine API for normal business operations after expiry of three months period from the date of this order.

The DoP order further said that NPPA and DCGI are also empowered to extend these directions to any other producers of API D-Pencillamine or formulations in India during this three months period. This order will be valid for next three months and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period.