Indian pharmaceutical companies are stepping up their efforts to combat the problem of counterfeit drugs, employing a variety of strategies, from packaging innovations to engaging private investigation agencies. The stakes are high, as counterfeit medicines not only harm consumers but also tarnish the reputation of leading brands.
The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products
Cadila, Biocon developing rapid antibody testing kits; Eris, Mylan, Gland importing. There are two kinds of testing for the novel coronavirus - the real-time polymerase chain reaction test kit that uses throat or nasal swabs and provides results in a few hours, and the other is antibody-based rapid testing kit that use blood samples and provides results in a few minutes.
Corporate India is starting to step up its capital expenditure plans amid government incentives and signs of rising demand, company executives and analysts have indicated. This coincides with the Reserve Bank of India (RBI) recently citing a double-digit growth in private capital expenditure. Healthy balance sheets of banks and corporates, along with increasing capacity utilisation and improving business sentiment, are contributing to a favourable environment for sustained growth in private sector investments, the RBI said in its policy last week.
The top 300 pharmaceutical brands in the country will now bear a quick response (QR) code on their packaging to rein in spurious drugs and ensure better traceability.
Drug shortages in the US are at an all-time high, and price erosion has stabilised, which could benefit Indian pharmaceutical (pharma) companies with a US focus, according to analysts. Nuvama Research analysts said that US price erosion seems to have normalised to its old levels of 6-8 per cent and volumes are picking up with easing of inventory. Similarly, an ICICIdirect analyst noted: "Price erosion intensity has now moderated to a single digit and is expected to tone down a
Those leaving the company include Nikhil Chopra, head of India business, Nikhil Lalwani, who served as head of US business, and Kunal Khanna, head of chronic and emerging therapies.
Nutraceuticals, consisting of dietary supplements and functional foods with curative or nutritional benefits, are estimated to have a sales of $190 billion globally by 2010. India's food supplement and health food market is estimated currently at about $400 million. The country already has a clutch of established players focussing in this segment such as Avesthagen, Himalaya and Sami Labs.
ZyCoV-D is a three-dose vaccine administered intradermally.
Pharmaceutical industry experts said the US move had come as a boon for the Indian drug exporters as the law could clear the alleged doubts on the quality and the genuineness of Indian pharmaceutical and raw material products.
PM Modi said that it was an honour to be a trusted partner during the pandemic adding that the two countries will continue to strengthen cooperation on healthcare.
Novartis said it is partnered with generic drugmaker Lupin Ltd to sell the drug in India
During the meeting, scheduled to be held through video conference at 6 pm on Tuesday, the Department of Biotechnology will make a presentation and also coordinate with all the participants, sources added.
The company has not yet revealed details about the unexplained illness but has stopped trials while doctors find out if the illness was caused due to the vaccine or was a coincidence.
But no extra risk after second dose, shows study led and funded by drug maker, reports Sohini Das.
While sales in the domestic market declined 4.2 per cent during the April-July period, exports grew steadily at 9.5 per cent during the same period.
Rosier year-end seen for Indian pharma thanks to faster US approvals.
They seek to profit from big-selling drugs going off-patent this year in the lucrative market.
All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.
Acquisition to boost its generics business in developed markets.
In a landmark judgment that has the potential to change the direction of India's pharmaceutical business, the Supreme Court said on Monday that the drug failed to qualify for a patent according to Indian law.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
Some of the popular brands that would be impacted include Phensedyl (Abbott), Tixylix (Abbott), Gluconorm PG (Lupin), Ascoril D (Glenmark), Solvin Cold (Ipca), D Cold Total (Paras Pharma).
The next hearing on Pfizer's plea is slated for March 21
Recently, Ranbaxy and Wockhardt too were hauled up.
Is yet to decide about the partnership or acquisition route
Avigan comes in a complete therapy pack of 122 tablets with a two-year shelf life.
The situation is severe in North India as most of the logistics operation was manned by migrant labourers from Uttar Pradesh and Bihar. The problem with manpower is not only in courier and delivery services, but also at a shop level.
The comments came after AstraZeneca and Oxford University acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.
Hetero has priced the injectable drug at Rs 5,400 per 100 mg vial. With More drugmakers in line to launch the drug soon, the prices may see a further erosion.
India's largest drugmaker, Ranbaxy, will have an exclusive six-month marketing opportunity to sell a generic version of Japanese drugmaker Eisai's drug for Alzheimer's in the US.
Prime Minister Modi has said India's vaccine production and delivery capacity will be used for the benefit of all humanity to fight the COVID-19 pandemic. He said last week India was ready to do everything possible for a healthy planet.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study.
Court has barred generic drugmaker Cipla Ltd from making or selling a cheaper copy of Novartis AG's respiratory drug Onbrez domestically.
Favipiravir is the only oral anti-viral treatment approved in India for potential treatment of patients with mild to moderate Covid-19 disease.
Cipla has agreed to buy two generics businesses in the United States in an all-cash deal worth $550 million.
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
"Pfizer's proposal would dramatically dilute AstraZeneca shareholders' exposure to our unique pipeline and would create risks around its delivery," Chairman Leif Johansson said.
