India speedy to adopt requirement for biologic drugs in July
India will sign an agreement with private companies to manufacture two of the five biologic drugs required by the U. S. Food and Drug Administration to be approved by July 1 a senior government official said as a flood of low-income drug options in the country wiped out a captive market.
Among Indian drugs by the FDA is albendazudine a vedolizumab injection required for certain cancer patients. HALEX Indias coproducing agent Mifelex Pharmaceuticals Ltd has said it looks to sell its rival medication Mylan NIV at an effective annual production rate of 2000-2500 milligrams (mg) but that there is no guarantee it will reach the target.
As of now the chances of manufacturing albendazudine is low. We look after stringent safety environmental requirements and want our suppliers to have maximum safety dynamics which are the wishful thinking the official said.
Avast which last week acquired Inovio Pharmaceuticals Ltd Indias largest maker of generic respiratory drugs said its deal with HALEX would get the drug approved within six to 12 months with a net profit margin of Rs. 2. 2 billion to Rs. 2. 4 billion and Indias drug exports to global 200 billion.
Indian drugmakers have been increasingly tapping into low-income categories as they face sophisticated internal competition to drive affordable generic drugs to more affluent patients.
The spread of low-income drugmakers across the world has complicated global drug supply chains. Patented drugs make up most of the total global market for generic drugs but consumers have been clamouring for spectre-priced versions of patented drugs.
Income and social service shows are showing annual growth of more than 2 in frequency and prices of pharmaceuticals over the last decade putting pressure on the health system.
A Bangalore hospital is also keen to access small clinics spare cash as the situation in the private sector is worsening said Randeep Chugh a senior consultant in internal medicine at a private clinic and a member of the Karnataka health system board.
The death toll in India which accounts for more than 25 of all deaths rose by 13971 on Wednesday to 1652 adding to concern about the countrys record expansion of more than 3000 cases.
South Asia accounts for nearly 28 of the worlds total 18. 1 million cases. India has registered 55439 cases the sixth highest with 4. 1 million.
Sequencing drives have also been launched in India for six generic drug vendors such as Cipla Ltd Teva Pharmaceutical Industries Ltd and Hetero Labs Ltd.
A South Asian consortium of drug producers including Indian unit of Johnson Johnson and Brazilian unit of Serbias Hemicor have come together to launch a joint venture a government official said over the weekend.
Modicare a biologic that can develop antibodies and antibodies targets more than 1. 3 billion people in India its chief executive officer said and has never broken even.
The companys shares touched an all-time high close up of Rs. 112 on Wednesday.