NEWS

GROWTH IN PHARMA SECTOR (25/09/2017)

The pharma sector is expected to grow by 20 per cent on account of relaxed foreign direct investment (FDI) norms and a separate ministry to focus on the sunrise sector is on the anvil, Chemical and Fertiliser Minister Ananth Kumar today said. 

While continuing with 100 per cent FDI under automatic route in greenfield pharmaceuticals, the government had earlier this week allowed 74 per cent foreign investment in brownfield pharma companies through the automatic route. 


The pharma sector is expected to grow by 20 per cent on account of relaxed foreign direct investment (FDI) norms and a separate ministry to focus on the sunrise sector is on the anvil, Chemical and Fertiliser Minister Ananth Kumar today said. 

While continuing with 100 per cent FDI under automatic route in Greenfield pharmaceuticals, the government had earlier this week allowed 74 per cent foreign investment in Brownfield Pharma companies through the automatic route.

Bill to amend existing Drugs Act withdrawn (25/09/2017)

As part of the health ministry's move to replace the old laws governing India's pharmaceutical and medical devices industries, the government on Wednesday withdrew a Bill introduced in Parliament in 2013 to amend the existing Drugs and Cosmetics Act.
According to a statement released by the government, work is underway on two separate Acts— one to regulate drugs and cosmetics and the other for medical devices.
While a draft set of Rules to regulate medical devices under the existing Act has already been prepared, the ministry has also begun work on the separate Act for medical devices, the statement said.
The government had earlier banked on amendments to the existing 1940 Drugs & Cosmetics Act, introducing amendment bills in the Rajya Sabha between 2013 and 2015.
The Union Cabinet has withdrawn the Bill and is now focusing the new Acts that would be better suited to accommodate  innovations and developments in pharma, healthcare and medical devices sector.
The government also aims to improve ease of doing business for the industries without compromising on safety, efficacy and quality of treatment here through this move, according to the government's statement. The Cabinet has, keeping in view the role of the sector in managing public health, decided that it will not be appropriate to carry out further amendments in the present Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial/investigation, etc. cannot be effectively regulated under the existing law," the statement said.
"Keeping in view the objective of make in India, it has been decided to comprehensively review the existing bill laws. 

Government invites entries for NPPA logo (25/09/2017)

The Department of Pharmaceuticals plans to differentiate drugs under price control and make it easier for patients to identify them by printing a logo of price regulator NPPA on packages. The department is seeking designs of logo for National Pharmaceutical Pricing Authority (NPPA) through a public contest. 
"The basic idea is that there should be a symbol displayed on scheduled medicines, so that even an illiterate consumer can identify that the medicine is under price control.

The rationale behind the move is that the consumers understand if a medicine has the logo then its price is fixed and therefore he or she can't be overcharged, the official added. DoP is looking for a logo of NPPA which would carry a tag 'Medicine under price control/UPC' that can be used on medicine strips, labels and on medicine bottles. 

Government set to release revised biosimilar guidelines in July 2016 (25/09/2017)

The government is set to release the much awaited revised guidelines for the approval of biosimilar drugs in the first week of July, a move that would bring clarity to the launch of such drugs in the country.
Biosimilar drugs are copies of complex products based on living cells. The country's biosimilar guidelines were first unveiled in 2012. 
"These revised guidelines (on similar biologics 2016), expected in the first week of July, will not deviate much from the draft  released earlier in March," a senior health ministry official who did not wish to be identified told ET. 

At the same time, the final revised guidelines clarify parts of the draft that could have been interpreted in more ways than one, the official said. 
The ministry expects the final guidelines to uphold the safety and efficacy of biosimilar drugs hitting the Indian market through stringent requirements, according to the official. 
For instance, the guidelines mandate that no less than 100 patients be used in certain clinical trial phases, the official said. "Some countries .. 
The guidelines also specify the conditions that biosimilar makers need to meet to exempt themselves from certain clinical trials, the official said. 
The proposed changes in the draft guidelines, which could more than halve the approval time for biosimilars here, had earlier met with concerns from multinational pharmaceutical companies. The Organization of Pharmaceutical Producers of India (OPPI), a lobby group of MNC drug companies, had then suggested that the draft diluted requirements in the 2012 guidelines which could compromise patient safety. 

The latest revisions come amid questions from global drug makers like Swiss biotech giant Roche, which dragged the government to court over the process followed for approvals of a few such drugs. 
The Swiss drug maker recently sued the Drugs Controller General of India (DCGI) to block approvals for Hyderabad-based Hetero Drugs' 'biosimilar' of its blockbuster cancer drug, Avastin (bevacizumab). 

 

India beats China in pharma exports in 2015 (25/09/2017)

India's pharmaceutical fares proceeded with its lead over China in 2015, as indicated by the legislature.

India's pharma sends out grew 7.55% to $12.54 billion in 2015 contrasted with China's pharma trades, which grew 5.3% to $6.94 billion amid the same time frame, the service said in an official proclamation.

"India pushed forward of China in exceptionally imperative markets, for example, US, European Union and Africa," the service said.

India's fares of pharma items to US grew 23.4% to $4.74 billion from $3.84 billion, the service said. In the meantime, China's fares to the US amid the same time frame became just 15% to $1.34 billion from $1.16 billion, the service included.

As indicated by the service, India's pharma fares to the EU and Africa were likewise more noteworthy than China's in 2015. While India sent out $1.5 billion and $3.04 billion-worth of pharma items to the EU and African markets separately, China's e ..

"A sizeable measure of the crude material utilized as a part of pharma items sent out to Africa is transported in from China," he told.

India is likewise reliant on Chinese crude materials for pharma items sold inside the nation as a result of value control and solid rivalry between medication creators taking into account the Indian business sector, Veeramani included.

"In India, the cost has descended such a great amount of that, in rivalry, we need to purchase from China. Indian producers are not ready to beat the import cost from China.