Pharma News Highlights, January to February 2018

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Here are highlights of major news in Indian pharmaceutical sector from January 2018 to February 2018.

Sun Pharma gets 3 observations from USFDA for Halol plant: Sun Pharmaceutical said the US health regulator has issued three observations after inspecting its Halol facility in Gujarat.
(USFDA) conducted the Good Manufacturing Practices (GMP) inspection of the company’s Halol facility.

The Indian pharmaceutical market (IPM) grew 7.1 percent in February: helped by improved uptake in anti-infectives, respiratory and chronic segment like diabetes, according to market research firm AIOCD-AWACS. The growth, however, has slowed down as compared to January’s 9.5 percent.

Innian pharma cos get record 300 USFDA generic drug nods in 2017: Domestic pharma companies received more than 300 approvals in 2017 to launch generic drugs in the US, which is an all-time high. The clearances came despite regulatory pressure from the USFDA. The final approvals for Indian players are up by nearly 43% from 211 in 2016, and corner about 40% of all global filings in the highly lucrative around $70-billion US market.

A study found high levels of heavy metals and industrial solvents in Hyderabad’s water bodies: conducted by the European non-profit agency, Changing Markets, which was commissioned by Sweden-based Nordea Bank, claims to have found high levels of heavy metals and industrial solvents in Hyderabad’s water bodies.

Uttar-Pradesh new Pharma Policy: The UP state government is more than willing to extend all support to the pharmaceutical sector to make UP a hub of pharma industries like Himachal Pradesh and Gujarat. The state has formulated new pharma policy with several incentives for pharma sector.

Largest pharma conference: An international exhibition and conference on Pharmaceutical & Medical Device sector ‘India Pharma & India Medical Device 2018’ held at Bangalore. More than 20 international drug and device regulators  participated in a meet with Indian regulators. Ministerial delegations from CIS and BIMSTEC countries also attended the event. A key highlight of India Pharma & India Medical Device 2018 was a workshop by World Health Organisation on ‘Regulatory System Strengthening and Prequalification’.

Advanced cervical cancer needs chemo-radiotherapy, not surgery: An eleven-year-long trial by the Tata Memorial Hospital (TMH) has established that women with advanced cervical cancer should not be treated with surgery, which is widely offered the world over. Instead, a combination of chemotherapy and radiotherapy increases five-year survival chances. The trial highlights the need for India to vastly increase radiotherapy centres from the meagre 530 that exist today, that too mostly in metro cities.

New York City on Tuesday sued the makers of Opoid prescription painkillers:  such as OxyContin, Percocet and fentanyl that have played a central role in the opioid crisis killing tens of thousands across the nation.

US state Alabama day became the latest state to file a lawsuit accusing OxyContin: maker Purdue Pharma LP of fueling the opioid epidemic by deceptively marketing prescription painkillers to generate billions of dollars in sales.

Sun pharma recalling Nasal Spray: Sun Pharmaceutical Industries Inc, the US arm of domestic drug major Sun Pharma is recalling over 17.5 thousand bottles of antihistamine Azelastine HCl nasal solution from the American market, latest enforcement report of the US health regulator has said. The recall is due to failure in maintaining required droplet size .

AIIMS develops new drug delivery system for cancer:

Doctors at AIIMS Delhi have introduced a new technology for treating cancers affecting the abdominal lining, for example colon cancer or colorectal cancer. It involves administering heated chemotherapy drugs directly into the abdomen during surgery, Instead of infusing into the veins post-surgery to destroy cancer cells. With the new technology, doctors said they were able to deliver higher dosage of chemotherapy drugs.

Torrent Acquisition of Bio Pharm: Torrent Pharmaceuticals Ltd announced the acquisition of the US-based generic pharmaceuticals and OTC company, Bio-Pharm, Inc. (BPI) triggering the first M&A this year in the domestic pharma sector.

Sri lanka to build Pharma manufacturing Zone: Sri Lanka’s state Pharmaceuticals Manufacturing Corporation has signed 10-million-U.S. dollar agreement with Pharma Zone (Pvt) Ltd a Malaysian firm to build the island’s first ever pharmaceutical manufacturing zone in the southern district of Kalutara

India’s proposal to curb drug prices by stripping generic medicines of their brand names has stalled: reportedly after the plan faced pushback from the country’s pharmaceutical companies

Warren Buffet buys 2% stake in pharma company Teva: 

Warren Buffet is well known for his investment principles and his method of intrinsic value investing. Buffet buying stake in Teva could signal that the pharma companies probably have more intrinsic value that is perceived by the market.

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