Question: What number of Abbreviated New Drug Application (ANDA) approvals were received by Indian companies from US food and Drug Administration (USFDA) in 2017?
(a) 304
(b) 312
(c) 326
(d) 350
Answer: (a)
Related facts:
- The Drugs Technical Advisory Board (DTAB) recently recommended that government procurement agencies should take necessary steps in the tendering process to include the regional language, along with English, on the label of iron tablets and polio drops in government programmes.
- In order to counter fake, sub-standard and expired drugs, the Union Health Ministry has notified that Hindi and regional language will be used in the tendering process.
- Drug names and expiry date during tendering will be in Hindi/regional language too for – Polio drop and Iron tablets – procured for children under the government programmes.
- Since last year, the government has been working on ensuring the most stringent quality control for both the products which directly affect almost all the children born in India.
Indian Pharmaceutical Industry:
- Low cost of product and increasing expenditure on R&D has led to competitive pharma exports from with exports reaching 17.27 billion dollar in financial year 2018 and have reached 15.52 billion dollar up to January 2019.
- The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 % over 2015–20 to reach US$ 55 billion.
- Indian pharmaceutical sector industry supplies over 50 percent of global demand for various vaccines, 40 percent of generic demand in US and 25 % of all medicine in UK.
- The pharmaceutical sector was valued at 33 billion dollar in 2017.
- India’s domestic pharmaceutical market turnover reached Rs. 129,015 crore in 2018, growing 9.4 percent year-on-year from Rs. 116, 389 crore in 2017.
- Indian companies received 304 Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration in 2017.
- The allocation to the Ministry of Health and Family Welfare has increased by 13.1 percent to Rs. 61, 398 crore in Union Budget 2019-20.
Links:
https://www.thehindu.com/sci-tech/health/medicine-labels-in-regional-language/article26905354.ece
https://www.ibef.org/industry/pharmaceutical-india.aspx