Life-saving Wilson's disease treatment available in India once again: Government
NEW DELHI: Months after a reported shortage of the life-saving D-Penicillamine medicine to treat Wilson’s disease, the country's drug regulator claims it has remedied the problem. The regulator says the shortage occurred due to non-availability of the active pharmaceutical ingredient (API)—the raw material used to give the drug its therapeutic effect.
Wilson’s disease is 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. One out of every 30,000 people are afflicted with Wilson’s, according to Wilson’s Disease Association (WDA) International.
In September 2016, CDSCO stepped in to address concerns over a "severe" shortage of D-Penicillamine, one of the medicines used to treat Wilson's.
"As per the available information and response from the patients, there seems to be no shortage of D-Penicillamine Capsules in the country as of now and the issue is resolved," stated Indian Drugs Controller General (DCGI) GN Singh on Friday.
While the DCGI confirmed that non-availability of the API was the reason for the shortage, he added that its supply was restored following bilateral talks to expedite the inspection of a manufacturer of the API in China.
"CDSCO has convened meetings with all the existing manufacturers and also with those who have capabilities and interest for launching the drug in the country," Singh stated.
Industry sources earlier argued that the shortage occurred because suppliers of the medicine’s most crucial raw material had begun to favour other markets for better margins once the drug came under price control.
Companies had approached the government asking to allow them to import the API on an emergency basis as opposed to waiting for nearly half a year to import it through regular procedures, some industry officials earlier told ET.
D-Penicillamine is estimated to be a Rs 4-5-crore market in India, an official earlier told ET on condition of anonymity.
Apart from D-Penicillamine, there is reportedly another drug—Trientine dihydrochloride—that treats the disease, but it is not produced in India.
Wilson’s disease is 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. One out of every 30,000 people are afflicted with Wilson’s, according to Wilson’s Disease Association (WDA) International.
In September 2016, CDSCO stepped in to address concerns over a "severe" shortage of D-Penicillamine, one of the medicines used to treat Wilson's.
"As per the available information and response from the patients, there seems to be no shortage of D-Penicillamine Capsules in the country as of now and the issue is resolved," stated Indian Drugs Controller General (DCGI) GN Singh on Friday.
While the DCGI confirmed that non-availability of the API was the reason for the shortage, he added that its supply was restored following bilateral talks to expedite the inspection of a manufacturer of the API in China.
"CDSCO has convened meetings with all the existing manufacturers and also with those who have capabilities and interest for launching the drug in the country," Singh stated.
Industry sources earlier argued that the shortage occurred because suppliers of the medicine’s most crucial raw material had begun to favour other markets for better margins once the drug came under price control.
Companies had approached the government asking to allow them to import the API on an emergency basis as opposed to waiting for nearly half a year to import it through regular procedures, some industry officials earlier told ET.
D-Penicillamine is estimated to be a Rs 4-5-crore market in India, an official earlier told ET on condition of anonymity.
Apart from D-Penicillamine, there is reportedly another drug—Trientine dihydrochloride—that treats the disease, but it is not produced in India.
