Indian pharma exports hit $19.14 bn, report double-digit growth after 3 yrs

Source: Business Standard, May 03, 2019

Hyderabad: Pharmaceutical Export Promotion Council (Pharmexcil)’s year-end report has pegged the total pharma exports from India at $19.14 billion for 2018-19 with a growth of 10.72 per cent over $17.28 billion in pharma exports last year.

The double-digit growth has returned to pharma exports after three years of flat-to-marginal export growth, driven by formulations exports to North America among other destinations, according to the report. Read the rest of this entry »

Pharma exports increase 11% to $19.2 billion

Source: The Hindu Business Line, Apr 23, 2019

New Delhi: The country’s pharmaceutical exports rose 11 per cent to $19.2 billion in 2018-19, mainly driven by higher demand in regions such as North America and Europe, as per a Commerce Ministry data.

The pharma exports in 2017-18 stood at $17.3 billion and $16.7 billion in the previous fiscal.

North America constitutes about 30 per cent of Indian pharma exports, followed by Africa and the European Union with 19 per cent and 16 per cent share, respectively, according to the data.

According to industry experts, the Chinese market is also gradually opening up and the government is working to push India’s exports there as it holds huge potential. Read the rest of this entry »

Combination drug market declines 56% in March as govt clamps down

Source: Business Standard, Apr 11, 2019

Mumbai: With the government clamping down on combination drugs, the latest market data shows that in March the fixed dose combination (FDC) market declined by 56.4 per cent, when the non-FDC market showed a growth of 9.2 per cent and single molecules grew by 9.4 per cent.

An FDC drug is one that contains two or more active ingredients in a fixed-dosage ratio. Last year, the government had banned over 340 ‘irrational’ FDCs, which were found to be posing health risks to patients. More FDC drugs are under the scanner at the moment, which may also come under the ban.

As a result, pharmaceutical companies have pared their exposure to FDCs and are also restricting the launch of new combination drugs. “Before the ban was enforced mid-last year, we had braced for the same and weeded out FDCs from our domestic portfolio. Read the rest of this entry »

No clinical trials in India for new drugs approved in select developed markets

Source: LiveMint.com, Mar 26, 2019

New Delhi: New drugs approved for use in select developed markets will be automatically allowed in India if the global trials included Indian patients.

The new Drugs and Clinical Trials Rules, 2019, has done away with the formality of conducting local trials so that the drugs can be introduced in Indian markets sooner.

“The move is expected to reduce the time taken by the company to introduce the drug in India and prevent duplication of studies. For example, if a US-based company conducted clinical trials that also included Indian patients and the drug is marketed in the US, there will be no need for conducting local clinical trials to prove its efficacy in India,” a senior government official said, requesting anonymity.

Requirement of local clinical trials has also been waived off for the drugs approved and marketed in the European Union, the UK, Australia, Canada, Japan and the US. “Data generated outside the country will be acceptable,” the official added. Read the rest of this entry »

Cold wave across US to bring big business for Indian drug companies

Source: Business Standard, Mar 11, 2019

Mumbai: The cold wave in the US may bring big business for domestic pharma firms. The cold conditions there have resulted in spike in flu cases. Companies such as Cadila Healthcare, Lupin, and Natco, which sell generic versions of flu medication (Oseltamivir) in the US market, are likely to benefit.

The flu medicine market doubled in 2017-18 from the 2016-17 levels. According to data from the US Center for Disease Control and Prevention, there have been 20.4 million to 23.6 million flu illnesses in the US between October 1, 2018, and February 23, 2019. This caused 16,400 to 26,700 deaths there.

Natco, which launched its generic version of Tamiflu in the US in December 2016, reported a decline in the drug’s sales in recent times. After the third quarter results, Natco indicated that the decline in profits during the quarter was mainly due to margin reduction in its product Oseltamivir in the US. Tamiflu is a Roche brand. Its capsule version (an estimated $500-million market) has seven generics and the suspension (an estimated $250-million market) has four generics. Read the rest of this entry »

National drug pricing regulator fixes retail value of 36 formulations

Source: Business Standard, Feb 27, 2019

New Delhi: National drug pricing regulator NPPA has fixed the prices of 36 formulations, including those used for treatment of cancer, diabetes, infections, asthma, seizures, inflammation and pain, among others.

In a notification, the National Pharmaceutical Pricing Authority (NPPA) said it has fixed retail prices of 22 formulations and has revised ceiling price of 14 formulations.

Among the formulations whose ceiling prices have been revised include Budesonide inhalation used for preventing symptoms of asthma and Gentamicin injection used for treatment of bacterial infections. Read the rest of this entry »

Rise in imported API costs may lead to hike in drug prices

Source: The Hindu Business Line, Feb 18, 2019

New Delhi: There is a speculation that prices of certain drugs may go up, considering that costs of Active Pharmaceutical Ingredients (API) that India imports from China have increased compared to last year.

“This comes in the light of re-opening of revamped Chinese facilities that had shut shop last year, due to regulatory issues,” said Karthikeyan Thangaranjan, Associate Director, India Ratings and Research Pvt Ltd.

Costs of certain APIs, which are the core ingredients that go into formulation of drugs, had doubled over the last year, as over a lakh Chinese facilities closed. “Prices of APIs and key starting materials originating from China have started to moderate but are likely to settle at higher-than-the-previous-average levels. We are speculating a 20-30 per cent rise in costs of certain APIs that India imports from China,” Thangarajan told BusinessLine. Read the rest of this entry »