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With the declaration of union budget 2018-19, which was very much in favor of Indian healthcare sector and now USFDA giving approvals to the drugs especially to the Indian pharmaceutical companies, the healthcare sector seems to be on the run to touch zenith in business.
Government’s Focus:
As per Ananth Kumar, Union Chemicals and Fertilisers Minister, The government is looking to bring in a new pharma policy for implementing the proposed health care plan across the country in the next couple of months.
Kumar added that "We are for a reform of regulatory rules and regulations governing pharma and medical devices without compromising on quality and affordability. These are the touchstones for pharma and medical devices by the government of India.”
Pharma and Medical Devices sector will be a major employment provider going forward, he added.
"We have a global presence and supply pharmaceutical to more than 215 countries and are the third biggest manufacturers. Compared to the global growth rate of 5 percent we are growing at the rate of 15 percent," Kumar said.
What is USFDA?
As medicinenet.com describes, the Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
FDA is responsible for: Protecting the public health by assuring that foods (except for meat from livestock, poultry, and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled.
It ensures that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.
Developments in Drug Companies:
- The recent development that took place in the healthcare sector is that Strides Shasun got a nod from USFDA for its generic Efavirenz tablet used for the treatment of HIV Type-1 infected adults and adolescents.
- Drug firm Jubilant Life Sciences has received final approval from the US health regulator for Amantadine Hydrochloride tablets, an anti-viral and anti-Parkinson’s drug. The approved drug, generic version of Symmetrel of Endo, is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus.
- Lupin has launched its Tydemy tablets followed by the approval from USFDA. Lupin said the approved Tydemy tablets are indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception.
- Lupin has also received approval from the USFDA to market a generic version of Tami flu capsules, used in treating influenza.
- Lupin has received approval from the USFDA to market its generic Doxycycline hyclate tablets, used for the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne.
- Glenmark Pharmaceuticals has received final approval from the USFDA for a generic version of Minastrin 24 tablets used for prevention of pregnancy.
- Zydus Cadila has received approval from the US health regulator for its generic version of Tizanidine tablets used for the treatment of muscle spasms.
- Zydus Cadila has also received final approval from US health regulator to market Dexmedetomidine Hydrochloride injection used for sedation of intubated and mechanically ventilated patients.
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