After EU, Lincoln Pharma gets Australian approval for plant

India-based Lincoln Pharmaceuticals Ltd said it is looking forward to entering the Australian market, after Australia’s medicines and medical devices regulator – Therapeutic Goods Administration {TGA) – approved the company’s primary manufacturing plant in Khatraj, Gujarat. The approval, said the medicine manufacturer, has been granted for all three sections, tablets, capsules and creams & ointments. […]

Brickwork Ratings says telecom reforms not enough

Brickwork Ratings, a credit rating agency that gives advice on the ability of companies to service their debt, has hailed the slew of measures announced by the government yesterday to give relief to the telecom sector, but added they’re not enough to save the industry. FLIP FLOP The most import measure announced yesterday was a […]

RattanIndia to benefit from new drone rules

RattanIndia, a company focused on next-generation and disruptive businesses and led by Indiabulls founder Rajiv Rattan, said it expects to benefit from the new drone rules announced by the government this week. Government of India had, earlier this week, announced several far-reaching regulatory changes aimed at allowing people to use drones or unmanned aerial vehicles […]

Zydus Cadila gets nod for ZyCoV-D DNA COVID vaccine

Zydus Cadila has finally said it got Emergency Use Authorization (EUA) from Indian authorities to administer ZyCoV-D — the world’s first DNA-based COVID-19 vaccine — for both adults and teenagers. This is the first time any COVID-19 vaccine has been approved for those below 18 years of age in India. The approval has been given […]

Vodafone Idea hopeful of justice in AGR case

Vodafone Idea is hoping that it will be able to do a better job of convincing Supreme Court of India to allow the government to rectify the mathematical and compilation that crept into the calculation of its humongous regulatory levies that now threaten its very existence. A Supreme Court bench headed by Arun Mishra had […]

Alkem’s Taloja test facility passes US FDA inspection

Pharmaceuticals manufacturer Alkem Laboratories said its bioequivalence center at Taloja in Maharashtra has successfully undergone a US FDA inspection without attracting any adverse remarks. “US FDA had conducted a remote and virtual Bio-Analytical inspection of the Company’s Bioequivalence Center located at Taloja, Maharashtra from 26th July, 2021 to 28th July, 2021. At the end of […]

Adani says FPI accounts not frozen

Adani Transmission, a part of the diversified Adani Group, disputed a report by financial newspaper Economic Times that said that NDSL had frozen the share accounts of three foreign investors who held nearly Rs 43,500 cr worth of stock in various Adani group companies. Economic Times had carried the news quoting an update published by […]

Lupin gets US FDA warning letter for Somerset plant

Lupin Ltd, one of the world’s largest generic drug makers, today said it received a warning letter from the US Food and Drug Administration relating to its US-based manufacturing plant located in Somerset, New Jersey. “We wish to inform you that the Company has received a warning letter from the US FDA for the company’s […]

Airtel Digital partially implements TRAI Tariff Order

Airtel Digital, one of the top television channel distributors in India, has partially complied with TRAI’s tariff order as amended on January 1 this year. The company has complied with some provisions of the rules, such as reducing the network charge for up to 200 channels, while compliance with other parts of the tariff order […]

Cable/DTH operators ignore TRAI’s new tariff order

Most cable and DTH operators in India have failed to comply with TRAI’s tariff order issued that came into effect today in perhaps the first such incident in the industry’s history. As of today, the amended provisions of the Telecom Services Tariff Order, notified two months ago, have come into place. However, as of 8 […]

Javadekar supports changes to TRAI tariff order

The recent changes made to the TV channel pricing rules of India by the Telecom Regulatory Authority of India to the tariff order on January 1 are targeted at dealing with the problems faced by the consumer and balancing the interests of various industry participants, Minister of Information and Broadcasting Prakash Javadekar said today. The […]

Biocon gets Form 483 observations for API plant

The US Food and Drug Administration has issued a Form 483 with five observations for Biocon’s API Manufacturing facility. Form 483 observations are issued when US FDA inspectors notice shortcomings in a company’s manufacturing processes, data storage and so on during an inspection. The company has to address the issues raised in the Form 483 […]

TRAI TARIFF ORDER: Jaya TV becomes the first to publish prices

Mavis Satcom, which operates channels under the Jaya TV banner, has become the first broadcasting company to comply with regulator TRAI’s order to publish updated channel prices by end of day today. The company published prices of four channels and one bouquet. The channel prices remain unchanged and range from Rs 0.50 for Jaya Plus […]

No stay on TRAI’s Tariff Order from Bombay HC, yet

The Bombay High Court did not issue a stay on the implementation of the amended TV channel tariff order issued by TRAI on News Year’s day, but kept the possibility open when it takes up the case again on January 22. Broadcasters, under the aegis of Indian Broadcasting Foundation, had approached the Bombay High Court […]

Broadcasters challenge TRAI’s amended tariff order

With just two days remaining for a deadline to file amended TV channel tariffs, a case filed by India’s big broadcasters in the Bombay High Court has been listed for hearing tomorrow in front of Justice SC Dharmadhikari. Broadcasters, including Star India, Zee Entertainment, Sony Networks and others, have come together under the banner of […]

Cadila Healthcare gets US FDA warning letter for Moraiya facility

Cadila Healthcare, one of India’s biggest pharmaceutical companies, said it has received a ‘warning letter’ from the US Food and Drug Administration relating to its Moraiya formulations facility in Gujarat. The Moraiya facility is the company’s largest plant that makes tablets and injectables and is estimated to contribute about 40-50% of its U.S. exports. Shares […]

TV channels get price-cuts ahead of new pricing formula by TRAI

Some of the popular television channels owned by major broadcasters like Star India, Zee Entertainment and TV18 have seen their prices reduced on a temporary basis as the broadcasting regulator puts the final touches on a new law aimed at bringing down individual channel prices and curbing anti-competitive practices. The cuts come barely a week […]

Tata Sky slashes monthly charge under TRAI tariff scheme

Tata Sky, a premium satellite TV provider in India, has unveiled a scheme by which heavy customers can bring down their monthly network fee by up to Rs 300. However, to get the lower network charge — also known as network capacity fee or NCF — a subscriber must buy some television channels picked by […]

Cadila Healthcare Moraiya plant could face FDA action

Cadila Healthcare today said that the US FDA has classified its Moraiya factory near Ahmedabad as ‘official action indicated’ or OAI. OAI is one of the three types of classification that a plant inspection report is put under after an FDA inspection. The three classifications are ‘no action indicated’, ‘voluntary action indicated’ and ‘official action […]