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 »

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High drug approvals to keep up pricing pressure for pharma firms

Source: LiveMint.com, Jan 16, 2019

December quarter earnings of pharmaceutical companies may see incremental improvement helped by a favourable base and steady domestic business. But if the drug approvals trend in the US is anything to go by, pricing pressure in the key market is unlikely to abate anytime soon.

As approval rates gathered pace and increased competition eroded prices, earnings of domestic pharmaceutical firms came under pressure, forcing reorganization of their US businesses. With new business lines yet to acquire scale, the generic drugs business still remains core to the companies’ earnings.

As the chart shows, the year ended September 2018 has seen a record 781 abbreviated new drug application (ANDA) approvals by the US Food and Drug Administration (FDA). Read the rest of this entry »

Indian pharma industry records 9.4% growth in 2018, dispels GST gloom

Source: Business Standard, Jan 09, 2019

Mumbai: The domestic pharmaceutical industry bounced back to a nearly double-digit year-on-year growth in 2018 (9.4 per cent), after falling to an eight-year low (5.5 per cent) in the previous year. The industry’s size was Rs 1.29 trillion last year.

In 2017, growth of the industry was hampered primarily by the transition to the goods and services tax (GST), rolled out on July 1 of that year. Delayed product approvals and inclusion of more products under price caps were other reasons. Read the rest of this entry »

Booster dose for pharma as Govt okays refund on foreign plant inspection

Source: Business Standard, Jan 08, 2018

Hyderabad: Pharmaceutical companies can now claim reimbursement of costs incurred on plant inspections conducted periodically by overseas regulatory agencies.

The Union Commerce Ministry has revised the Market Access Initiative Scheme (MAI Scheme) along with guidelines related to reimbursement of expenditure incurred by Indian exporters on statutory compliance in the buyer country, while including additional components, besides raising the fund limit.

The Ministry has added plant inspection charges for pharmaceutical products as eligible for funding assistance under MAI, and has raised the ceiling to Rs 2 crore a year per exporter from the present Rs 50 lakh. According to the new guidelines, any exporting company can claim reimbursement of charges incurred towards statutory compliances on a 50:50 sharing basis up to a maximum amount of Rs 2 crore in a year. Read the rest of this entry »

Govt may not proceed with draft pharmaceutical policy

Source: The Hindu Business Line, Jan 03, 2019

The much-debated Draft Pharmaceutical Policy which was discussed in closed door meetings through last year may not see the light of the day after all.

Jai Priye Prakash, Secretary, Department of Pharmaceuticals (DoP), told BusinessLine on the sidelines of a conference that the impending amendment to the Drug Price Control Order (DPCO), 2013, as obviated the need for a policy.

The policy, which addressed a host of issues including limiting the role of the National Pharmaceutical Pricing Authority in fixing drug prices, and delegating the authority to draw up the National List of Essential Medicines to the DoP instead of the Ministry of Health, had attracted widespread criticism.

Sources in the DoP said the amendments to the DPCO include not bringing orphan drugs like Myozyme and Fabrazyme, which are used in the treatment of rare genetic diseases under price control, as it will discourage their indigenous or generic production. Currently, orphan drugs are hard to access and are mostly imported at a huge cost. Read the rest of this entry »

Online medicine startups in funding frenzy as sector consolidates

Source: LiveMint.com, Dec 18, 2018

Bengaluru: Online medicine delivery startups, such as PharmEasy, 1mg, Netmeds and LifCare, are racing ahead of the pack by raising large sums of capital and putting pressure on their peers to either keep raising cash or sell out.

PharmEasy recently raised more than $50 million in two tranches, while 1mg is in advanced talks to close a $60-80 million round, according to two people familiar with the developments.

Netmeds, which recently secured $35 million, is in talks with investors to raise more money, another person familiar with the matter said. LifCare raised around $11 million in July from the likes of Saif Partners and Nexus Venture Partners.

Investor bullishness in this sector comes in the wake of the union health ministry issuing in September draft rules on the sale of drugs through e-pharmacies with final regulations expected by the end of this month. However, according to a Times Of India report, Delhi high court ordered on Wednesday a ban on the sale of online medicines by e-pharmacies, making it a risky investment. Read the rest of this entry »

Soon, trade names of drugs may be regulated

Source: LiveMint.com, Nov 29, 2018

Drug pharma companies may not be able to repeat the same trade names for different drugs, after changes to rules aimed at helping consumers avoid confusion. The central drug regulatory authority is likely to amend the drugs and cosmetics rules to include a provision for regulating brand names by the central licensing authority, said two people aware of the matter.

Currently, trade names of drugs are neither controlled by the licencing authority nor the trademarks office.

India’s top drug advisory board will discuss the issue in a meeting on Thursday. Health officials said the move can help ensure patient safety. “Too many medicines in India are being sold under similar brand names, putting patients at risk,” said the first person cited above.

The Union health ministry held a meeting on 13 November to discuss the issue of brand names and trade names of pharmaceuticals, concluding that it is neither controlled by the licensing authority under the drugs and cosmetics Act nor the trademarks office, which leaves companies free to manufacture and sell different drugs under the same trade names. Read the rest of this entry »