Lupin’s Aurangabad plant passes USFDA inspection

Pharma manufacturer Lupin said its Aurangabad factory has successfully obtained an Establishment Inspection Report (EIR) from the US FDA for its May inspection. The receipt of an EIR signifies the successful closing of the inspection as far as the company is concerned. Lupin’s Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral […]

Caplin Point Labs gets 2 observations from US FDA for Chennai plant

Pharmaceuticals maker Caplin Point Laboratories said the US FDA has completed inspection of its Sterile Injectable manufacturing facility at Gummidipoondi in Chennai and issued two observations. The good manufacturing process inspection was done between June 6th and 14th. “The Company believes these to be of procedural in nature and the corrective and preventive actions for […]

Way2Wealth: SAT stays SEBI order in NSE leased line case

The Securities Appellate Tribunal has stayed an order by the stock markets regulator imposing strict restrictions on stock broker Way2Wealth in the ‘NSE leased line’ case. The Securities and Exchange Board of India had, two weeks ago, imposed penalties and restrictions on several parties, including the National Stock Exchange, for facilitating or indulging in unfair […]

Boeing 737 MAX: Spicejet suspends 14 flights, offers refunds

India’s most aggressive low-cost carrier, Spicejet, said it has cancelled 14 flights today due to the grounding of multiple Boeing 737 MAX aircraft. The grounding is the result of a regulatory directive, which was prompted by an accident with an Ethiopian Airlines plane last week, the second Boeing 737 MAX to fall out of the […]

TRAI TARIFF ORDER: Calcutta High Court lifts stay, gives breather to LCOs

The Calcutta High Court has vacated the stay it imposed on the implementation of the new tariff scheme by TRAI, even as it gave extra time for cable operators to negotiate a deal with their feed suppliers. The stay was imposed two days ago after cable operators said that the new rules would hurt them […]

US FDA issues observations on Lupin Pithampur plant

Pharmaceutical company Lupin said that the US food and Drug administration has issued six observations after an inspection at its Pithampur manufacturing unit. The inspection was conducted between 14th and 25th January said the company. All companies are supposed to observe good manufacturing practices issued by the US FDA when producing food and drugs meant […]

Tata Sky gives in to TRAI, announces new channels and packs

Tata Sky, India’s second largest TV channel distributor, finally unveiled its channels and packs under TRAI’s new tariff rules — and offered support to almost all broadcaster’s plans and packs. Tata Sky consumers can log on to or to modify their existing packs and packages and select the new bouquets and packs under […]

CHANNEL PRICES: TRAI botches new tariff rollout; could hurt BJP in 2019

The curious case of TRAI’s implementation of the its 2017 Tariff Order, which threatens to add yet another negative factor for NDA in upcoming polls, can be an excellent case study of what ails India’s legal and regulatory system. The saga started almost two years ago with four companies — Star India, Discovery Communications, Tata […]

Tata Sky, Sun Direct miss TRAI deadline for new channel packs

India’s largest DTH operator Tata Sky and smaller rival Sun Direct have missed TRAI’s deadline to introduce new, more transparent channel prices to their subscribers from midnight. Even as other cable and DTH players, like Airtel Digital, Dish TV, D2h, Hathway, Den Networks, Siti Cable and GTPL started displaying the new prices for TV channels, […]

DTH customers on long duration packs to get TRAI plans from Dec 29

Subscribers of Direct-to-Home satellite services on all existing plans, including long-duration packs, will be migrated to schemes compliant with TRAI’s tariff order on TV channels from 29 Dec, according to Dish TV, India’s biggest DTH operator. The company said the TRAI rules are applicable to all customers and there is no exemption for any category, […]

MCA orders inspection into Vakrangee’s accounts

Vakrangee Ltd, the Mumbai-based technology and distribution company, said the ministry of corporate affairs of India has ordered an inspection of its accounts for three years, and that PricewaterHouse will step down as the company auditor as part of the exercise. The inspection will be carried out under section 206 of the Companies Act. The […]

Lupin’s Goa plant completes successful inspection by UK MHRA

Pharma major Lupin said its Goa facility has successfully completed an inspection by the UK Medicines and Healthcare Products Regulatory Authority. “There were no critical or major observations in the inspection,” it said, indicating that products made at the facility can continue to be sold in the UK market. This is not the first such […]

Multiplexes to allow ‘outside food’ from Aug 1

Multiplex theaters in Maharashtra will have to allow customers to carry their own food items into the exhibition hall, Maharashtra government said in the legislative assembly. The statement by consumer affairs minister Ravindra Chavan in the assembly comes in the context of a public interest litigation being heard in the Mumbai High Court about ‘overcharging’ […]

Airtel Payments Bank: RBI lifts ban on new signups

Bharti Airtel said the Reserve Bank of India has lifted the restriction on signing up new customers imposed on its banking unit Airtel Payments Bank. The restriction was imposed in January after reports that the company was signing up its mobile customers on its payments bank platform without seeking their full consent. Payments Banks are […]

CCI probe to have no material impact – ONGC

India’s largest oil and gas producer said the move by the Competition Commission of India to initiate a full investigation into the way the company hires offshore support vessels will have no material impact on the company. Under SEBI guidelines, listed companies must disclose any development that will have a material impact on the company […]

USFDA completes inspection at Zydus’ Ahmedabad plant

Pharmaceuticals maker Zydus Cadila said the USFDA has completed an inspection of its injectables manufacturing plant at Ahmedabad with zero observations. No observations is good news for pharma manufacturers as it indicates that the inspectors found everything to order. The inspection of the plant, located at an SEZ in the city, was conducted between May […]

USFDA approves Dr Reddy Lab’s UK plant after seven-month scrutiny

The United States Food & Drugs Administration has closed its audit of the UK manufacturing plant of Dr Reddy’s Laboratories, the Indian pharmaceutical company said. In September last year, the company had announced that the US FDA issued a Form 483 with three observations regarding operations at the pharmaceutical drug manufacturing plant at Mirfield, leading […]

RIL says tax tribunal satisfied with Biometrix deal

Reliance Industries said it was not aware of any inquiry into the funds received by entities connected with it or its promoters from Singapore-based Biometrix Marketing. It also said, as far as it was aware, that the Income Tax Appellate Tribunal “was satisfied with the source of funds”. The clarifications came after report by the […]

Lupin gets tentative USFDA approval for billion-dollar testosterone drug

India-based pharma major Lupin said the US drugs regulator has granted it a conditional, or tentative, approval to sell a generic version of the popular testosterone gel AndroGel. AndroGel, made by AbbVie Inc, is a big-selling drug with annual sales of well over $1 bln. AbbVie, which has patents valid up to 2020 on the […]

Vedanta denied permission to restart smelter operations at Thoothukudi

Vedanta, one of the world’s largest metal producers, said its application for renewal of consent for operating its smelter plant in Thoothukudi in Tamil Nadu has been rejected. The company had shut down the copper smelting plant on March 27 “as part of a regular maintenance program,” it said. “..the Company had applied for renewal […]