Introduced in 2015 under the Foreign Trade Policy, the mega MEIS was created out of a merger of five existing reward schemes.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
The firm, however, said the anti-cholesterol tablets meant for the US market will be produced at its Mohali SEZ plant in Punjab and not at the three units banned by the US health regulator.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
The company did not comply to the 'good manufacturing practice' norms.
India consistently ranked among the top three countries whose products were rejected for import by the regulator.
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
The company has received a communication from the Medicines and Healthcare Products Regulatory Agency, United Kingdom, whereby the agency has decided to withdraw the previously issued GMP Certificate to the company's manufacturing facility situated at Kadaiya, Nani Daman, Wockhardt said in a filing to the Bombay Stock Exchange.
To set up a future-ready administration geared towards the target of $2 trillion exports by 2030, the Department of Commerce has decided to set up a dedicated trade promotion body to drive overall promotion strategy, export targets, and execution as part of a restructuring exercise. The trade promotion body will formulate and drive overall trade promotion strategy; create and drive India's branding across focus markets and sectors; drive coordinated action across missions, states and export promotion councils; strategic initiatives, including advisory and buyer-seller meet; and develop digital platforms for exporters and buyers. Based on a 14-volume 'restructuring dossier' by the Boston Consulting Group, the commerce department has already implemented some of the recommendations.
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.
Indian policymakers must realise that in buying small quantities of equipment, it becomes hard to start manufacturing them in India, explains Ajai Shukla.
The government has allowed import and export of COVID-19 vaccines without any value limitation, in order to ensure speedy clearance and distribution. The Central Board of Indirect Taxes and Customs (CBIC) has amended the regulations to facilitate the import/export of COVID-19 vaccines through courier, at locations where the Express Cargo Clearance System (ECCS) is operational. "Imports and exports of vaccines in relation to COVID-19 has been allowed without any value limitation," said the amended Courier Imports and Exports (Electronic Declaration and Processing) Amendment Regulations, 2020.
The Narcotics Control Bureau (NCB) on Saturday said it has arrested Jaffer Sadiq, a Tamil Nadu-based alleged dealer of narcotics, in connection with an international drugs trafficking investigation case.
Data also show that several other leading domestic pharma companies have recalled their products from the US
India and the US on Thursday said they are looking forward to the reconvening of the India-US Trade Policy Forum later this year to further enhance trade relationship and identify new areas for engagement.
US President Barack Obama said there is natural convergence between India and the United States.
In contrast with their strong performance in 2020 and 2021, pharmaceutical and healthcare funds experienced a decline in 2022, with returns plummeting by an average 9.8 per cent. This trend has continued in the current year, with year-to-date return remaining in the negative (-4.9 per cent). In the past three months, pharma funds have been hit hard, experiencing a 7.9 per cent decline.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
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.
The further expansion and upgrade of the Chinese military does not augur well for India, which continues to confront an increasingly belligerent China on its borders, notes former foreign secretary Shyam Saran.
Drug firm Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.
The results of the assembly elections in Gujarat and Himachal Pradesh are likely to play out during the winter session of Parliament beginning Wednesday.
The flight, carrying 216 passengers and 16 crew, landed safely, the Tata Group-owned private carrier said in a statement Tuesday evening.
Overall, the credit profiles of players will be supported by healthy balance sheets and liquidity. Prudence in capital and development expenditure, efficient working-capital management, and recent equity raising will help sustain credit metrics in FY22.
A panel led by the secretaries of the DEA and the DIPP would conduct a quarterly review on the pending proposals.
Ankleshwar plant is the third such facility to face action
The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products.
Once tipped to emerge as the biggest exporter, the pharmaceutical industry is yet to acquire the scale of those in software services, says Krishna Kant.
SEZs account for just about a third of India's merchandise exports (and roughly the same proportion of services exports). Yet, the notion of creating global manufacturing centres of the kind that propelled China to superpowerdom retains a durable appeal within the Indian policy-making establishment, notes Kanika Datta.
China has given conditional approval for a single dose COVID-19 vaccine, touted to be a rival to Johnson & Johnson's one-jab shot cleared by the United States drug regulator on Sunday.
The court directed the Union and the Maha governments to file their affidavits by April 21, pointing out the parameters followed for the regulation and distribution of Remdesivir vials.
The company had posted a consolidated net profit of Rs 323.31 crore (Rs 3.23 billion) in the same period last fiscal, Wockhardt Ltd said in a filing to the Bombay Stock Exchange.
The move assumes significance because a go-ahead from the US Food and Drug Administration for the new unit in Visakhapatnam is likely to give a huge boost to the company's revenues in upcoming quarters.
Recently, Ranbaxy and Wockhardt too were hauled up.
.jpg)
The company had in May announced that the US Food and Drug Administration had issued an import alert on its Waluj facility, which makes injectables and solid dosages.
India has been the single biggest beneficiary of the decades-old US Generalized System of Preferences programme, allowing the country to export $ 5.7 billion worth of duty-free goods in 2017, according to figures from US Congress.
