The disappearance of life saving drug D-Penicillamine from the market

Alarmed at the disappearance of life saving drug D-Penicillamine from the market, which is used to treat Wilson’s disease, the central drug regulator has called a meeting with five major pharmaceutical companies, which are involved in its sale, on Friday.

The five firms which have been requested by Central Drug Standard Control Organisation (CDSCO) to attend the meeting “without fail” are German Remedies, Panacea Biotec, Samarth Lifesciences, VHB Lifesciences and Chandra Bhagat Pharma Private Limited.

Wilson’s diseases is a rare genetic disorder which prevents the body from getting rid of extra copper. The build up of copper may damage liver, brain, kidneys and eyes. D-Penicillamine is known to remove excess copper via urine.

“As per the representations (to CDSCO), 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,” said the letter written by Deputy Drugs Controller R Chandrashekhar to the five companies.

Panacea Biotec, Samarth Lifesciences, VHB Lifesciences and Chandra Bhagat Pharma Private Limited have been selling this medicine in India under the brand name Cilamin, Distamin, Artamin and Atrmin, respectively.
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“Therefore, a special meeting on the subject matter will be held by Dr G N Singh, Drug Controller General of India on September 30 (Friday)…to gauge the situation and examine the remedies to make the drug available in the country,” the letter added.

According to a September 16 petition on change.org by Wilson’s disease patient Piyush Gattani, the reason for this ‘real or artifical’ shortage is the government’s decision to bring this drug under price control.

“This drug’s price has been fixed by drug price controller at Rs 138 per strip of 10 capsules. This molecule is not manufactured in India and it is imported, then capsulised and then sold by few pharmacy companies like VHB Lifesciences, Samarth Pharma, Chandra Bhagat Pharma. Due to non availability of raw material and higher cost due to duties, etc, it is no longer cost effective for them to import and sell this medicine.

Probably this is the reason for the shortage,” Gattani said in his petition which requests government aid for patients suffering from the disease.

“Government might have taken the decision in interest of the patients, however it has become counterproductive. DPCO should have kept the price which would have not caused the pharmaceutical companies to go in losses. This would have helped,” he added.


http://indianexpress.com/article/business/business-others/d-penicillamine-life-saving-drug-disappears-from-market-cdsco-calls-for-meeting-3056870/