GST notices to pharma firms on free supply to have wider ramifications

Source: Business Standard, May 31, 2018

New Delhi: Notices sent by the tax department to major pharma companies over not cutting the Goods and Services Tax (GST) on free supplies to retailers are likely to have repercussions on fast-moving consumer goods (FMCG) companies as well, warn tax experts, who found no ground for the notices.The notices sent by the Directorate General of Goods and Services Tax Intelligence (DGGI) say that some free supplies of drugs – injections, tablets, syrups – have been made to stockists and retailers without charging GST on them.

Abhishek Rastogi, partner with Khaitan & Co said: “The issue of free supplies will have wider implications on diverse sectors, including FMCG and apparels. This means that the implications could arise whenever discount is offered by way of a quantity discount.”

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Commerce Ministry in talks with Chinese FDA for speedy approval of Indian pharma products

Source: The Hindu Business Line, May 14, 2018

Hyderabad: Indian pharma companies may look forward to speedy product registrations with the Chinese Food and Drug Administration (CFDA).The Pharmaceutical Export Promotion Council (Pharmexcil) had requested the Department of Commerce to pursue the issue with CFDA officials.

“The process is on, and the issue has already been discussed at the highest level,” Pharmexcil Director-General Uday Bhaskar told BusinessLine on Monday.

According to data available with the council, 254 product registrations are pending with the Chinese regulator. “The delay in registration has been a problem, as the CFDA has taken 3-5 years to approve,” Uday Bhaskar said. The US FDA, on the other hand, takes not more than three years. The matter is significant in view of the growing interest of Indian drugmakers in the Chinese market, with active pharmaceutical ingredients (APIs) forming the bulk of exports. Pharma exports to China registered a 37 per cent increase, from $145 million in FY17 to $200 million in FY18, according to Pharmexcil data. North America is currently the Indian pharma industry’s largest market, accounting for over 31 per cent of total exports. In recent years, there has been increasing interest from China too, the Pharmexcil official said, adding: “Some companies prefer Indian APIs. We expect this trend to pick up further.”

The Commerce Ministry has sought various details from Pharmexcil, including the number of product registration applications filed with the CFDA over the past two years, the number of applications currently pending with the Chinese regulator, and the reasons cited by the CFDA for the pendency. The council has asked its members to submit the data.

 Pharma exports

After remaining in the negative territory for the first five months of FY18, pharma exports increased YoY from November despite a slowdown in the US. Though the cumulative data for FY18 shows a modest 2.91 per cent growth to $17.27 billion from $16.78 billion in FY17, annualised shipments have gone up 14 per cent since November 2017.

 

Govt tweaks certification norms to aid pharma trade

Source: LiveMint.com, May 09, 2018

New Delhi: The government has decided to increase the validity of the World Health Organization’s (WHO) good manufacturing practices (GMP) certification to three years from the existing two years for companies exporting pharma products to other countries.

The move is expected to boost pharma exports and aims to promote ease of doing business.

The certificate of a pharmaceutical product (COPP) is issued under WHO GMP based on guidelines laid down by the health agency and is aimed at diminishing the risks inherent in pharmaceutical production. The certificate helps the regulator ensure that drugs are consistently produced and are quality controlled before they leave the country.

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Soon, a new set of rules for e-pharmacies

Source: The Hindu Business Line, Apr 25, 2018

New Delhi: The Health Ministry is planning to bring in a new set of regulations for online sale of medicines, under which e-pharmacies will need to be registered with a central authority and would not be allowed to sell narcotics, tranquilisers and psychotropic drugs.

The Ministry of Health is planning to bring amendments to the Drugs and Cosmetic Rules, 1945, to bring the regulations for e-pharmacies, and the draft rules have been shared with states and comments of state drug regulators sought, a ministry official said.

Online pharmacies have to register with the Central Drugs Standard Control Organisation (CDSCO) and they will not be allowed to supply drugs under the narcotics, psychotropic and tranquiliser categories, according to the draft rules.

 No specific regulations

Though there are already a few online retailers who deal in medicines, but there is no specific regulations for such activities. E-pharmacy registration holders will also have to establish and maintain a portal for the management of business, it said.The portal will have details of logistic service providers, a written policy of supplied drugs and their contact details, as per the draft rules. There should also be a mechanism in place to enable customers to lodge their grievances, it said.

“The aim is to monitor the sale of drugs through e-pharmacy and also the genuineness of the supply of medicines,” the official said. E-pharmacy registration holders would have to provide 24X7 customer support. The registration certificate is valid for a period of three years from the date of its issue, according to the draft rules.

The new set of regulations will also make medicines more accessible and available at peoples’ doorstep.

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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