**Summary:**
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has received reports indicating a nationwide shortage of the life-saving drug D-Penicillamine. This shortage is of critical concern due to the absence of alternative treatments for Wilson's disease. To address this issue, Dr. G.N. Singh, Drugs Controller General of India (DCG I), will convene a meeting on September 30, 2016, at 2:00 PM at FDA Bhawan, Kotla Road, CDSCO HQ, New Delhi. The purpose of the meeting is to assess the situation and identify solutions to restore the availability of D-Penicillamine in the country. The following pharmaceutical companies have been requested to attend: Ms German Remedies, Ms Panacea Biotec, Ms Samarth Lifesciences, Ms VHB Lifesciences, and Ms Chandra Bhagat Pharma Private Limited. Contact person for the meeting is R. Chandrashekar, Deputy Drugs Controller India. File No.: 120116DC Pt155.
Key Entities Referenced
Central Drug Standard Control Organization: A regulatory body under the Directorate General of Health Services, Ministry of Health and Family Welfare, responsible for drug regulation in India.
DPenicillamine: A life-saving drug that was reported to be unavailable across India.
India: The country where the drug unavailability issue is taking place.
Wilsons disease: A disease for which DPenicillamine is a critical treatment.
Dr. G.N. Singh: The Drugs Controller General of India (DCGI) who will hold a meeting regarding the DPenicillamine availability issue.
FDA Bhawan, Kotla Road, New Delhi: Location of the CDSCO headquarters and the venue for the meeting.
Ms German Remedies: One of the pharmaceutical companies invited to the meeting.
Ms Panacea Biotec: One of the pharmaceutical companies invited to the meeting.
File No. : 12-01/16-DC (Pt-155)
Central Drug Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
(New Drugs Division)
FDA Bhawan,
Kotla Road, New Delhi,
Dated: 2% .09.2016
Subject: - Non availability of life saving drug (D-Penicillamine) across India
~ regarding
With reference to subject matter I am directed to inform that
CDSCO has received various representations regarding the non
availability of life saving drug (D-Penicillamine) in the Country. As per the
representations, the drug has disappeared from the market in the recent
past and it is no more available in the country. The availability of the
drug is very important as there are no alternatives for the treatment of
Wilson’s disease. Therefore, a special meeting on the subject matter will
be held by Dr. G.N. Singh, DCG (I) on 30.09.2016 at 02:00 P.M, 1s
Floor, FDA Bhawan, Kotla Road, CDSCO (HQ), New Delhi — 110 002, to
gauge the situation and examine the remedies to make the drug available
in the country
You are requested to make it convenient to attend the said
meeting without fail.
(R. Chandrashekar)
Deputy Drugs Controller (India)
To
1. M/s German Remedies.
2. M/s Panacea Biotec.
3. M/s Samarth Lifesciences.
4. M/s VHB Lifesciences.
5. M/s Chandra Bhagat Pharma Private Limited