Drug regulator plans national digital database of pharma manufacturers

downloadSource: The Economic Times, Apr 02, 2018

India’s drug regulatory body is creating a national digital database of pharmaceutical manufacturers and their medicines so regulators can be more effective when acting on problems like drug shortages and quality issues, people aware of the development told ET.

The Central Drugs Standard Control Organisation (CDSCO) is finalising software for this and plans to amend rules for drugs and cosmetics to make it mandatory for manufacturers to regularly put facility and product details in this database, they said.

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10 years of pharmaceutical sector: Controls, regulations stymie growth

Source: Business Standard, Mar 21, 2018

Ahmedabad: The past 10 years have been eventful for pharma. The domestic market has grown to Rs 1.1 trillion from Rs 363 billion in 2008. There have been 97,240 brand launches, and exports, led by the US market, almost doubled from $8.7 billion in 2008-09 to $16.88 billion in 2016-17.

It has also been a decade of major mergers and acquisitions, the most noteworthy one perhaps being the Sun Pharma-Ranbaxy deal and the epic hostile acquisition of Israel’s Taro by Sun Pharma.

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Regulator plans single-window system for new drug approvals

Source: LiveMint.com, Mar 08, 2018

New Delhi: In a move aimed at boosting the Make in India initiative, the Drug Controller General of India (DCGI) proposes to set up a single-window facility for innovators and start-ups seeking consents, approvals and information.

DCGI plans a separate public relations (PR) office which can be approached by innovators and start-ups seeking information regarding regulatory requirements for commercialization of products as well as clarifications on the Drugs and Cosmetics Act 1940 and other rules.

“The office shall guide assist and handhold investors in various phases of business life cycle as per the existing focus on Invest India/Make in India,” said an office memorandum. Mint has reviewed the copy of the memorandum.

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Modicare to be part of India’s new pharma policy

Source: LiveMint.com, Feb 16, 2018

Bengaluru: India’s ambitious National Health Protection Scheme (NHPS), dubbed “Modicare”, proposed in the Union Budget 2018, will be part of a pharmaceutical policy to be announced soon.

In what is claimed to be the world’s largest such scheme, the government proposes to provide health cover of up to Rs5 lakh per year to 500 million people from financially vulnerable households for free treatment of serious ailments. The budget has set aside an allocation of Rs2,000 crore for the scheme in 2018-19.

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Govt may cap trade margins to control drug prices

Source: LiveMint.com, Feb 14, 2018

New Delhi: The government is planning to cap how much drug retailers and wholesalers can earn on medicines they sell in an effort to arrest rising drug prices.

The Department of Pharmaceuticals (DoP) has recommended an increase in trade margins, or what wholesalers and retailers earn on the sale of medicines, on all drugs with maximum retail price (MRP) above Rs2 per unit—i.e. per tablet, capsule, vial, tube, bottle, injection, etc.—while retaining it at the current level of 30% for those priced below Rs2, two people aware of the matter said.

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Indian pharma firms renew focus; Dr Reddy’s, Cipla eye $100-bn China market

download (1)Source: Business Standard, Feb 14, 2018

Mumbai / Ahmedabad: Dr Reddy’s Laboratories (DRL) is expanding its presence in China, the world’s second-largest pharmaceutical market, where other drug manufacturers such as Cipla and Lupin are exploring opportunities.

The more than $100-billion China market is dominated by local drug manufacturers and multinationals and India’s pharmaceutical exports of around $160 million are a fraction of the companies’ sales.But recent changes in regulation allowing quicker product approval and growth opportunities in China have been drivers for Indian companies.

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Indian drug firms’ growth slowed in 2017 on slow approvals, MNCs’ caught up

download (1)Source: Business Standard, Feb 07, 2018

Ahmedabad: Home-grown pharmaceutical companies in 2017 saw some erosion in their edge over multinational peers in the domestic drug market. Tempering the past year’s trend of a significant lead, Indian drug firms grew at almost the same rate as their MNC counterparts.

While Indian pharma players clocked a 5.54 per cent growth rate during 2017, multinational ones grew at a shade higher (5.55 per cent rate), show data. This was partly because overall pharma growth slowed during the year, thanks to several factors, even as multinational companies saw a few months of high growth with specialised product launches.download (3).jpg

According to data sourced from AWACS, the market research wing of the All India Organisation of Chemists and Druggists (AIOCD) which represents over 500,000 medicine sellers across the country, the Indian pharma market (IPM) clocked 5.5 per cent growth in moving annual turnover (MAT) value – the lowest rate in eight years.

In 2016, IPM had grown 10.68 per cent – home-grown companies, with 11.85 per cent growth, had beaten the industry rate, while multinational firms with a presence in the domestic market had clocked 6.42 per cent growth.

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