A ban by the European Medicines Agency on some 700-odd drugs will hit $1.2 billion (Rs 7,700 crore) worth of Indian pharma exports to the European Union. The ban will come into force on August 21.
India’s pharma exports to the EU area are valued at Rs 20,000 crore and they account for about 20 per cent of total pharma exports of Rs 1,00,000 crore. Exports to the EU markets have been growing at 18 to 20 per cent every year.
“For the 700 authorisations given by the European Union on the basis of clinical studies conducted at GVK Biosciences, our estimate is that $1-1.2 billion exports would be affected,” said PV Appaji, director general of Pharmaceutical Export Promotion Council of India or Phamexcil.
The government has viewed this as an unfair and unjustified, which would affect the industry adversely.
The commerce ministry will review the situation over the next few days. Phamexcil, too, has been asked to give its view, he said. The 700 drugs banned in the EU are made by multinational or Indian companies or both.
However, Indian companies would account for about 30 per cent of the $1.2 billion exports that are at stake due to the ban, Appaji said, adding that Pharmexcil did not segregate the contribution of MNCs or Indian companies. India’s total exports to the EU comprise $1 billion worth of formulations and $2 billion worth of APIs. “There could be a slowdown or negative growth in exports to the EU. That will affect the Indian pharma sector. The US, despite hardships, is slowly recovering. The EU now has become an issue,” he said.
In January, the European Medicines Agency (EMA) recommended that a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad should be suspended.
The recommendation is based on findings from an inspection by French medicines agency ANSM. The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies on generic medicines. Such manipulations appeared to have taken place over at least five years.
Their systematic nature, extended period of time during which the trials took place and the number of staff members involved cast doubts on the integrity of the way the trials were conducted at the site and on the reliability of the data generated there, according to the EMA portal.
On the request of the European Commission, EMA’s Committee for Medicinal Products for Human Use (CHMP) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site.
For over 300 of them, sufficient supporting data from other sources were available and EMA was satisfied with that.
The CHMP has recommended suspension of the drugs that lack data from other studies, unless they are of critical importance for patients. The decision on whether a medicine was critical for patients was with the national authorities of the EU member states. For medicines that are considered critical, companies are given 12 months to submit additional data.
However, there is no evidence of any harm or lack of effectiveness of drugs linked to the studies by GVK Biosciences. CHMP’s recommendations have been sent to the European Commission for a legally binding decision. This decision will apply to all member states irrespective of whether or not they have taken interim measures to suspend the medicines.
Products made by Mylan (donepezil and others), Teva Pharma (desloratadine), Glenmark (esomeprazole magnesium and others), SandoZ Pharmaceuticals (trimetazidine), Abbott Laboratories (escitalopram oxalate and others), Ranbaxy (aciclovir and others), Sanofi Aventis (ebastine), Zydus France (ibuprofen and others), Dr Reddy’s (valsartan and others), among others, figure on the list for which the marketing authorisations are recommended for suspension by the CHMP, according to EMA.
A GVK BIO spokesperson said despite all the evidence/data presented, the European Commission moved ahead making the EMA recommendation. “GVK BIO is disappointed with the fact that even after multiple appeals, a deeper scientific dialogue was not undertaken. GVK BIO will continue to work with the government of India and our customers to help resolve this.”
Since January 2015, several pharmaceutical companies had independently challenged the EMA recommendation. Other regulatory agencies, including the USFDA, and the same regulators from EMA/ANSM who visited GVK BIO in September 2014 and November 2014 did not express concern over the ECG (electro-cardiograms) studies done during the same period and audited during the May 2014 inspection, the company said.
India’s pharma exports to the EU area are valued at Rs 20,000 crore and they account for about 20 per cent of total pharma exports of Rs 1,00,000 crore. Exports to the EU markets have been growing at 18 to 20 per cent every year.
“For the 700 authorisations given by the European Union on the basis of clinical studies conducted at GVK Biosciences, our estimate is that $1-1.2 billion exports would be affected,” said PV Appaji, director general of Pharmaceutical Export Promotion Council of India or Phamexcil.
The government has viewed this as an unfair and unjustified, which would affect the industry adversely.
The commerce ministry will review the situation over the next few days. Phamexcil, too, has been asked to give its view, he said. The 700 drugs banned in the EU are made by multinational or Indian companies or both.
However, Indian companies would account for about 30 per cent of the $1.2 billion exports that are at stake due to the ban, Appaji said, adding that Pharmexcil did not segregate the contribution of MNCs or Indian companies. India’s total exports to the EU comprise $1 billion worth of formulations and $2 billion worth of APIs. “There could be a slowdown or negative growth in exports to the EU. That will affect the Indian pharma sector. The US, despite hardships, is slowly recovering. The EU now has become an issue,” he said.
In January, the European Medicines Agency (EMA) recommended that a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad should be suspended.
The recommendation is based on findings from an inspection by French medicines agency ANSM. The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies on generic medicines. Such manipulations appeared to have taken place over at least five years.
Their systematic nature, extended period of time during which the trials took place and the number of staff members involved cast doubts on the integrity of the way the trials were conducted at the site and on the reliability of the data generated there, according to the EMA portal.
On the request of the European Commission, EMA’s Committee for Medicinal Products for Human Use (CHMP) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site.
For over 300 of them, sufficient supporting data from other sources were available and EMA was satisfied with that.
The CHMP has recommended suspension of the drugs that lack data from other studies, unless they are of critical importance for patients. The decision on whether a medicine was critical for patients was with the national authorities of the EU member states. For medicines that are considered critical, companies are given 12 months to submit additional data.
However, there is no evidence of any harm or lack of effectiveness of drugs linked to the studies by GVK Biosciences. CHMP’s recommendations have been sent to the European Commission for a legally binding decision. This decision will apply to all member states irrespective of whether or not they have taken interim measures to suspend the medicines.
Products made by Mylan (donepezil and others), Teva Pharma (desloratadine), Glenmark (esomeprazole magnesium and others), SandoZ Pharmaceuticals (trimetazidine), Abbott Laboratories (escitalopram oxalate and others), Ranbaxy (aciclovir and others), Sanofi Aventis (ebastine), Zydus France (ibuprofen and others), Dr Reddy’s (valsartan and others), among others, figure on the list for which the marketing authorisations are recommended for suspension by the CHMP, according to EMA.
A GVK BIO spokesperson said despite all the evidence/data presented, the European Commission moved ahead making the EMA recommendation. “GVK BIO is disappointed with the fact that even after multiple appeals, a deeper scientific dialogue was not undertaken. GVK BIO will continue to work with the government of India and our customers to help resolve this.”
Since January 2015, several pharmaceutical companies had independently challenged the EMA recommendation. Other regulatory agencies, including the USFDA, and the same regulators from EMA/ANSM who visited GVK BIO in September 2014 and November 2014 did not express concern over the ECG (electro-cardiograms) studies done during the same period and audited during the May 2014 inspection, the company said.
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