Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
Overall slowdown in the economy and growing volumes of unbranded generic medicines in the domestic market are behind poor sales.
Besides opposing the suspension of three medicines, the sector has also questioned the process adopted by the government.
Donald Trump's Presidency of the United States will open new opportunities for India though certain sectors, especially pharma and IT, may face the heat if the incoming president decides to impose restrictions on imports and H1B visa regulations, experts said on Wednesday. Prime Minister Narendra Modi's friendly relationship with Trump will have a positive bearing on Indo-US relations but India may have to adapt its strategies to maintain cooperation in areas of mutual interest.
The API of Paracetamol, a fever and pain medication, has grown 25 per cent from Rs 450-480 per kg in December 2020 to Rs 580-600 per kg in April. When compared to the pre-Covid prices of December 2019, the surge is much steeper -- around 140 per cent, reports Sohini Das.
With intermittent disruptions in the supply chain of raw materials from China, the Indian pharma industry has braced itself with bigger inventory. Even smaller drug makers are now carrying a month of buffer stock of key raw materials, said industry insiders. The lockdown in various Chinese provinces, including Shanghai, is likely to delay shipments by two weeks to a month, said domestic players. Shipments are critical for the Indian drug industry, which imports 70 per cent of its raw material from China.
Industry associations and companies in the United States, including the US Chamber of Commerce, Coalition of Services Industries and the iconic bike company Harley Davidson have called on the Donald Trump dispensation to push India to reduce tariffs, non-tariffs, and regulatory barriers to boost American exports.
Terming the judgement as a 'landmark judgement' in favour of poor patients, domestic drug manufacturer associations, including Indian Pharmaceutical Alliance and Indian Drug Manufacturers' Association, hailed the apex court's decision.
Codeine-based formulations are under the scanner for misuse as a narcotic product.
'Kamal has surfed and navigated a lot of tidal waves, manoeuvring the peaks and troughs, combining rare intelligence and commonly available intuitions to overcome unimaginable crises all his life.' 'There is no looking back at the past, for his only motto has been 'Tomorrow belongs to us'!'
India will export anti-malarial drug hydroxychloroquine, high in demand globally, only to foreign governments and not to private companies, as the product is under prohibited or banned category of exports, sources said. Although exports of this medicine is completely banned, India has decided to export this anti-malarial drug in sync with its global commitment to deal with the coronavirus pandemic.
The government hopes that the PLI schemes would provide 200,000-300,000 direct employment over five years, according to sources in the know.
'The world over, everybody is asking for the same medicines, same APIs, same KSMs.' 'However, there is just one supplier -- China -- for the entire world.'
In May, price growth for drugs was in negative territory at (-)1 per cent
Several firms are stepping up to help their workforce cope with soaring temperatures
The pharmaceutical and the consumer durables sectors, which depend on China for imports, have not been impacted yet due to unrest in China with people protesting against lockdowns. But the lockdown could have an impact on the supply of components used in consumer durables if it continues for the next fortnight. In the pharmaceutical industry, Indian players import 66-70 per cent of their bulk drug requirements from China.
Gujarat has around 3,000 licensees for allopathic drug manufacturing, apart from around seven homeopathic licensees, 500 ayuvedic and 600-700 cosmetics licensees
Even as the Supreme Court had recently dismissed the industry's plea against prices fixed by the regulator and its timely implementation, the National Pharmaceutical Pricing Authority has asked companies to pay the overcharged dues with 15 per cent interest.
Mandatory prescription of generic names is not a complete solution. Rather, in the absence of a range of approaches, it could mean passing the choice of selecting a drug from a doctor to a pharmacist, says Chandrakant Lahariya.
There is a need to incentivise R&D investments, offer corporate tax concessions and establish an effective intellectual property rights regime in order to push the growth of domestic pharmaceutical industry, as per the industry bodies. Outlining the sector's wish list for the upcoming Union Budget, Organisation of Pharmaceutical Producers of India (OPPI) Director General Anil Matai urged the government to explore methods to incentivise R&D investments, such as deductions on R&D expenses, research-linked incentives for MNCs, and corporate tax concessions.
As many as 11 industry bodies related to food and pharma sectors on Thursday alleged that the food regulator FSSAI has become "den of corruption" and demanded a CBI inquiry into the functioning of the authority, which shot to limelight over the Maggi issue.
This is because while the emergency authorisation for treating Covid was a recent move, the drug has been used since years for rheumatoid arthritis and autoimmune lupus.
Exports of electronics goods has risen by 24 per cent from April to November as compared with the same period in the last fiscal, the largest increase out of India's top 10 export categories. The increase has been propelled by mobile exports under the Production Linked Incentive (PLI) scheme and has pushed electronics up from sixth to fifth position in the top 10. A gap of $200 million separates electronics from occupying the fourth position, currently held by drugs and pharmaceuticals at $17.9 billion.
The bone of contention is product approvals, which pharma and neutraceuticals companies say cannot be re-introduced through the regulation route
'There is not any negative connotation associated with it.'
Next week, US Secretary of State John Kerry travels to India for the fourth annual US-India Strategic Dialogue
Three employees of a Noida-based pharmaceutical firm, whose cough syrup is alleged to have led to the death of 18 children in Uzbekistan last year, were arrested on charges of manufacturing and sale of adulterated drugs, officials said.
The Delhi high court had earlier allowed Indian pharma major Wockhardt to sell its Ace Proxyvon tablets, which is a mixture of three salts -- aceclofenac, paracetamol and rabeprazol -- a combination that is banned.
Pharma body wants all excisable goods used for R&D purposes should be exempted from central excise duty.
As fear grips the world, demand for protective gear used by health care professionals and citizens is on a rise. And, supply disruption from China has opened a window of opportunities for Indian medical device makers.
The report also said that in past DEG outbreaks, manufacturers have been suspected of substituting DEG in the place of more expensive, pharmaceutical-grade solvents.
The bench also issued notice to Ramdev to show cause why contempt proceedings be not initiated against him.
With the government asking the companies to operate with only 50 per cent staff strength, and exports dipping to almost zero, the truck and bus drivers idling at the petrol pump say they hardly have any work now. At a petrol pump on the deserted Bavla-Changodar highway near Ahmedabad in Gujarat, several trucks and buses are neatly parked in a row.
In two separate affidavits filed in the apex court, Ramdev and Balkrishna tendered unqualified apology for the 'breach of the statement' recorded in the November 21 last year order of the apex court.
The Supreme Court on Tuesday tore into Patanjali Ayurved's defence for putting out misleading advertisements, rejecting the apology from yoga guru Ramdev and the firm's managing director Acharya Balkrishna as 'lip service' and warned them against perjury.
Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India.
Ramdev and Balkrishna have tendered an "unconditional and unqualified apology" before the apex court over advertisements issued by the firm making tall claims about the medicinal efficacy of its products.
The letter was the latest sign of US frustration about the business environment in India.
The Centre has asked traders and resellers of medical devices to register in an attempt to expand the ambit of regulating the medical devices industry in the country. The move can have far-reaching consequences for both consumers and traders alike as products like face masks or prophylactics - now sold through grocers and other channels - may face issues of availability. In a notification dated September 30, the union ministry of health and family welfare said anyone wanting to sell, stock, exhibit or offer for sale or distribute a medical device, including in-vitro diagnostic medical device, will need a certificate of registration.
The bench also cautioned Patanjali Ayurved and its officers from making any statements adverse to any system of medicine in the media, both print and electronic, in any form as they said in their undertaking before the court earlier.
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