India is facing a serious shortage of life-saving drug, 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.

Panacea Biotec, New Delhi; Fleming Laboratories, Hyderabad; VHB Life Sciences, Mumbai; Chandra Bhagat Pharma, Mumbai; Biophore Pharmaceuticals, Hyderabad; and German Remedies (A Division of Cadila Healthcare Limited), Ahmedabad are the major producers of D-Penicillamine in the country.

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 to address the issue. The DCGI office (CDSCO) has been receiving various representations regarding the nonavailability of D-Penicillamine in the country. As per the representations, the drug has disappeared from the market in the recent past.

In the meeting convened by the DCGI, 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 that at present the availability of bulk drug is also an issue as the suppliers of the drug’s most crucial raw material are now favouring other markets for better margins.

In the meeting, Panacea Biotec informed that since September 26, 2016 they have resumed limited production of the drug and have released 69,000 capsules through their distributors to cope with the temporary shortage of the drug. They have also delivered the drug to approximately 300 patients so far, who could reach them through various forums. It was also mentioned that they have launched a website www.cilamin.com for emergency supplies to patients and for access to latest information on its availability.
 
The firm also informed that they have registration for import of bulk Penicillamine from China. However the registered site is not manufacturing the drug since last six months. Therefore, they have identified another bulk drug source in China but the same is not registered in India. The firm requested for special consideration for import of the bulk from the said source so that continuous supply of the Penicillamine Capsules can be ensured.

In reply, DCGI informed that once application along with the required documents for import registration is received, the same can be processed expeditiously for grant of import registration. Panacea Biotec is one of the largest producers of the drug in India under its brand ‘Cilamin 250’.

The representative of Chandra Bhagat Pharma informed that they are involved in import of bulk and manufacture of Penicillamine Capsule under third party agreement from West Coast Pharma, Ahmedabad. Since 2010, they have marketed approximately 17 lakhs of Penicillamine Capsules. They have already import registration for import of Penicillamine Bulk from China which is valid till 2018. However, they informed that the manufacturer in China is presently renovating their facilities and not in a position to manufacture the API.

After reviewing the situation, the DCGI requested the firms to take all necessary steps on urgent basis to ensure uninterrupted supply of the Penicillamine capsules in the interest of patients.