Indian Pharma gets 9% more USFDA approval

Indian Pharma companies received 372 approvals to launch generic drugs in the US fiscal 2019, up 8.6% from 340 in the previous year. The development comes even as India got 15 warning letters in calendar 2018, lower than the US with 19, and China which topped the list with 24 warning letters. As against this, India had the ignominious distinction of topping the list with 9 warning letters in 2015 and has since appeared to have cleaned up this act.
In terms of approvals, Zydus Cadila topped the list with 60, with Indian companies cornering nearly 40% volume share in highly remunerative $60-billion-plus US generic market- a key driver of growth for the domestic industry. In an indication of having resolved data integrity issues by investing in skill sets, domestic companies grabbed the opportunity by the US Food and Drug Administration (USFDA) to speed up the generic competition.
Indian generic filings have been rising year-on-year, unfazed by regulatory pressure from the USFDA, and a spate of warning letters issued to their facilities over the last couple of years. Over 2015-17, Indian companies have faced intense regulatory glare from the US, with nearly all top companies having been issued warning letters over manufacturing violations at their plants. This seems to have changed last year with fewer warning letters for Indian companies, compared to other major countries.

However, in 2018 India received fewer warning letters compared to the other nations.

India to have 2,500 new hospitals in 5 years

At the launch of certificate course on ‘Specialist Training To Tackle The Burden of NCDs’ by Federation of Indian Chambers of Commerce and Industry (FICCI) , Member (Health) NITI Aayog Dr V K Paul stated that by simplifying the work in private healthcare sector won't just make new business openings yet in addition give better healthcare services. By 2024, India is likewise likely to accomplish the WHO standard of having one doctor for every thousand patients, he said.

FICCI working jointly with NITI Aayog to find innovative techniques for firming quantity of specialized doctors. In continuation to this, FICCI has collaborated with Extension for Community Healthcare Outcomes (ECHO) to dispatch the first of its caring Diabetes Certification Course for General Practitioners (GP), considering the WHO measurements of 69.2 million Indians enduring with diabetes in 2015 and insufficient endocrinologists to convey specific consideration.

According to Dr. Paul, association with the industry through FICCI makes the ECHO model extraordinary.

He emphasized on government’s arrangements to double the quantity of UG seats by 2024 yet achieving the required number of specialist doctors is a five times increasingly troublesome plan.

Originator executive of ECHO, Dr, Sanjeev Arora shared ECHO’s vision to reach to 1 billion lives by 2025 and out of 1 billion, achieving 400 million recipients in India by utilizing the ECHO model of incorporated guided practice to train doctors.

The preliminary project for FICCI-ECHO Diabetes Certification Course is a tele-tutoring program of 20-week duration tailored to train 100 GPs on logical management of diabetic patients.

According to Brig Dr. Arvind Lal, chairman, FICCI Health Services Committee & CMD, Dr. Lal Path Labs, by empowering GPs on diabetes the board can endlessly improve persistent outcomes as about 95% of the diabetics in India are being taken care of by primary care doctors, GPs and family doctors. It will develop an Indian model of healthcare.

Manoj Jhalani, MD, National Health Mission (NHM), Ministry of Health and Family Welfare, Government of India featured that "It is imperative to enable essential wellbeing groups and general doctors (GPs). The union health ministry additionally investigating participatory methodologies for connecting with a private division like a commitment for stipends paid to DNB students at both public and private hospitals."

Indian pharma exports hit $19.14 bn, report double-digit growth after 3 yrs

The recent annual report by Pharmaceutical Export Promotion Council (Pharmexcil) claimed that the total pharma exports from India have shown a heartening double-digit growth of 10.72 percent at $19.14 billion for 2018-19 as compared to last year’s pharma exports of $17.28 billion.

Earlier, the double-digit growth in Indian pharma exports was witnessed in 2015-16, when total exports of $ 16.89 billion were registered at a growth rate of 10.17 percent. The current double-digit growth occurred after three years of flat-to-marginal export growth, mainly driven by formulations exports to North America among other destinations

Giving a performance break-up of individual categories within the pharma segment, The Union Commerce Ministry's nodal agency said that the export of drug formulations and biologicals, which grew at 12.13 percent vis a vis total growth of 10.72 percent. Thus, drug formulations and biologicals added close to $1.5 billion to the total pharma export revenues this time around.

The data shows that formulations accounted for 70.87 percent of the total pharma exports in the year 2018-19, with a total contribution of $13.56 billion.

"India's export of generics is growing 2.2 times faster as compared to global generics market growth, which is reported to have grown at just over 5 percent in 2018 calendar year," Pharmexcil said. Except December 2018, which did not show promising growth, exports of formulations through the year has done well and the average exports of formulations during the year registered $1.14 billion a month, according to the report.

Bulk drugs and drug intermediates, which is the second big category of exports after formulations, grew at 10.48 percent to reach $3.9 billion as compared to $3.5 billion last year. Export of vaccines and surgical grew 1.31 percent and 3.19 percent at $661.93 million and $569.77 million respectively in 2018-19.

Herbal products, being the only category of pharmaceuticals that showed negative growth in exports this time, registered $299 million of exports as compared to $312 million in the previous year.

The top 25 export destinations contribute approximately three fourth of the formulation exports amounting to $10.38 billion. The US maintains the position of being the largest export destination with over 38.62 percent of the total generic exports to that country at $5.24 billion.

As per the data released by the Director-General Commercial Intelligence and Statistics (GGCIS) for the month of February 2019, the pharmaceutical agency maintained that the price erosion was beginning to stagnate and recovery in margins was seen in the US.

Indian companies alone got 538 authorizations (product approvals) out of the total 1638 market authorizations granted by the US Food and Drug Administration (US FDA) in the year 2018. Indian companies are facing intense competition there as many of their approved products have six or more companies competing. "Indian companies are required to file complex generic applications and also of biosimilars to steer away from intense competition and look for higher margins. Biocon has already made a beginning in biosimilars," the report said.