The government is currently working on formulating the guidelines for supervising conducting clinical trials in the country and soon it would come up with the details in this regard, Health Minister Anbumani Ramadoss said. Phase I clinical trials are the first stage of test of safety and efficacy of new drugs on humans after passing trials on animals.
The broader NSE Nifty too dived by 101.65 points, or 0.97 per cent, to close at 10,350.15.
The government plans to immunise 30 million people in the first phase, starting February, and by July, the target is to vaccinate 250 million people, reports Sohini Das.
Exports of 13 APIs - including paracetamol, tinidazole, metronidazole, vitamin B1, vitamin B6, vitamin B12, acyclovir, progesterone - along with formulations made from these APIs, would be restricted.
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
As part of its global expansion plans, Dabur Pharma has acquired the sales and distribution network of Thailand-based Bioscience for an undisclosed sum.
In April, Mumbai-based pharmaceutical company Wockhardt announced it had received five marketing approvals for its generic medicines, versions of those that have gone off patents, from the US Food and Drug Administration in five weeks.
MSD Pharmaceuticals, the wholly-owned subsidiary of US-based multinational drug company Merck, has chartered an ambitious growth plan to emerge as one of the top five pharmaceutical companies in India. The Merck subsidiary has plans to step up its research and clinical trial programmes in India, mainly in association with hospitals and universities.
A government committee is looking at going beyond mere economic considerations and recommend an essentiality-linked pricing structure, it is learnt.
Covering-up of short positions ahead of Thursday's expiry of August series in the derivatives segment gave equities a slight push
Top security czars of India, Russia, Iran and five central Asian countries on Wednesday pledged to work for ensuring that Afghanistan does not become a safe haven for global terrorism and called for the formation of an open and truly inclusive government in Kabul.
The Hyderabad-based manufacturer uses a proprietary adjuvant Algel-IMDG, which has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses.
The report also referred to Prime Minister Narendra Modi's visit to Israel in July 2017.
'You will still want to take all the necessary precautions, which is the right thing to do.'
Drug maker Lupin Ltd on Thursday said it would acquire 51 per cent stake in Belgium-based Artifex Finance CVA for an undisclosed sum.
"India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation's collective fight against COVID-19," tweeted the minister.
Multinational drug companies with research interests in India may soon find the market more lucrative. The government plans to revive, and may extend to foreign companies, the income-tax exemptions enjoyed by Indian research and development pharma companies till 2007.
Indian auto and pharma industries import several critical components and raw materials from China.
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The land parcel is located in South Mumbai's Tardeo neighbourhood and has a total area of 4,300 square metres (46,268 sq ft).
The FDA Commissioner Margaret Hamburg is slated to travel to India soon.
Doval said it is time for closer consultations, greater cooperation and coordination among the regional countries to deal with the challenges emanating from Afghanistan.
The Centre is looking to procure around 1 billion syringes between September and December to support the COVID-19 vaccination drive.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
"Sputnik will probably offer vaccines after June 20. They will start the vaccine production from the month of August. They are importing the vaccines right now, and they will allot a section of their imported vaccines to the Delhi government," he said.
Serum Institute already has two deals of 100 million each to supply the Oxford-AstraZeneca and the Novavax vaccine to Gavi-Covax at $3 per dose.
The pharmaceutical companies may suffer sales loss of Rs 3,000 crore (Rs 30 billion) if the government's span of control increases, as proposed in the new pricing policy for the medicines, a section of the industry said on Monday.
Several states and UTs including Delhi, Maharashtra, Karnataka and Telangana have decided to opt for global tenders for procurement of anti-coronavirus shots with the domestic supply falling short to meet the rising demand.
Two weeks after the vaccination programme started, about 37 per cent of the targeted 10 million healthcare professionals had received the first shot. This slow rate may prompt the government to allow vaccines in the private market sooner, to use up the doses before they expire, Sohini Das reports.
This is not just a Ranbaxy or Wockhardt problem, says K Satish Reddy
Under the proposed rules, individuals or companies will have to register with the central licensing authority to run an e-pharmacy; state-wide registration is not required.
They said 37.5 crore of Covishield doses from the Serum Institute of India and 28.5 crore Covaxin doses from Bharat Biotech will be procured by December.
Indian government has extended price caps to 39 more medicines ranging from commonly used diabetes drugs to antibiotics.
Ahmedabad-based Zydus Cadila, Bharat Biotech's intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
A global policy would reward firms which strive for higher quality.
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