India-based Pharmexcil plans to step up interaction between DCGI, DGFT and stakeholders to help exports from India...

Aiming to address woes of the exporters on a fast track basis, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged the commerce ministry to push for more high level interaction between the stakeholders, Drug Controller General of India (DCGI) and Directorate General of Foreign Trade (DGFT). The Council stressed that since 90 per cent of the problems faced by the exporters stem from either regulatory or trade related complications, it is only fair to intensify the meetings to boost their confidence.

This demand comes in the wake of growing incidence of discontent among the stakeholders over the lack of opportunity to deliberate on important issues with the drug regulatory and the trade body. Industry strongly feels that there is an urgent need to escalate the number of interactive sessions between the government agencies and the industry on point to pint agendas to expedite their issues. They fear that the delay in doing so will negatively impact the exports from the country.

Apart from that Pharmexcil is also planning to highlight other issues that have been plaguing the industry in recent times, with special reference to growing concern over product registration. It is understood that the exporters have been increasingly finding it difficult to financially cope with the huge product registration fees in some overseas market especially in the light of long delay in getting product registered, i.e. 3 to 4 years.

Dr P V Appaji, director general, Pharmexcil pointed out that many exporters, mainly those from the small and medium enterprises feel that it is becoming difficult for them to deal with the high fees of the same and has urged urgent intervention from the government on this issue. The Council also plans to press upon the issues of financial services, CST, excise duty, issues in duty on neutralisation scheme, which basically deals with compensation on duty suffered on imports etc among other.

“We want to assure the exporters that we will take all possible measures to address these issues of the exporters without any delay. Ever since the inception of the Council which is completing 10 years of services this month, we have been doubling our efforts to boost the confidence of the exporters with great initiative. Going in these lines we will make sure that all these issues of the exporters are duly addressed at the earliest,” Dr Appaji added.

CDSCO India - DCGI approves EPIRUS' Remicade biosimilar to market in India...

The Drug Controller General of India (DCGI) has approved marketing and manufacturing of Remicade (infliximab) biosimilar BOW015 of EPIRUS Biopharmaceuticals, Inc., a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies. BOW015 is the first infliximab biosimilar approved in India.

Ranbaxy Laboratories and EPIRUS Switzerland GmbH, a subsidiary of Boston-based Epirus Biopharmaceuticals, Inc., have signed a licensing agreement for BOWO15, a biosimilar version of infliximab during January 2014. 

Under the terms of the agreement, EPIRUS will develop and supply BOW015, and Ranbaxy will register and commercialize BOW015 in India as well as in other territories in Southeast Asia, North Africa, and selected other markets.

"With these final clearances, we are now able to deliver a high quality product to patients who may not be able to afford current treatment options," said Amit Munshi, president and CEO of EPIRUS. "We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets."

BOW015 is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

BOW015 will be manufactured by Reliance Life Sciences at a facility in Mumbai which was inspected and approved in July of this year. The DCGI has issued the final clearances for BOW015, and EPIRUS and its commercialization partner Ranbaxy Laboratories  expect to launch the drug, under the brand name Infimab, by the first quarter of 2015.

"We believe that the data supporting BOW015's clinical comparability to Remicade, presented earlier this year at the EULAR meeting in Paris, combined with EPIRUS' focus on emerging markets, will help expand patient access to this important medicine," added Jonathan Kay, M.D., professor of medicine and director of clinical research in the division of rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School. Dr. Kay serves as a clinical advisor to EPIRUS.

CDSCO India - Separate Regulatory Authority for Ayurvedic Drugs soon...

Companies like Himalaya, Dabur, Baidyanath and Charak might have to be more watchful now. The reason: The government plans to set up a separate regulator for alternative medicine streams like Ayurveda, Siddha, Homeopathy and Unani.

The health ministry has floated a Cabinet note to create Central Drug Controller for AYUSH (Ayurveda, Unani, Siddha and Homeopathic) stream of medicines.

The proposal was expected to be taken up by the Union Cabinet in two weeks, a senior official in the know told Business Standard.

"It will be an overarching body looking specifically into AYUSH products and standards. Initially, we are looking at creating 13 positions within the authority to frame standards and guidelines and monitor quality of AYUSH products sold in the country," said the official.

According to the official, the proposed regulatory authority would be equivalent to the Drugs Controller General of India (DCGI), which currently looks at all medicines sold in the country. However, like in the case of pharmaceuticals or allopathic products, licensing and approval of AYUSH products will continue to be under the purview of state drug regulatory authorities, which coordinate and follow standards set by the central authority.

Currently, all medicines, including AYUSH products, come under DCGI's purview and follow the guidelines primarily framed keeping in view allopathic drugs.

"There is a need to frame separate standards and guidelines for AYUSH products, which are very different from the allopathic ones. Also, it is important that officials looking at these products are trained specifically in these streams and have knowledge about these," said the official quoted above.

Also, DCGI is short-staffed to handle allopathic drugs, which are high in circulation.

A separate regulator to deal with issues related to AYUSH has become necessary in the light of the government's major plans to push development of alternative medicine streams.

The Department of AYUSH, under the health ministry, also recently invited consultants and market research agencies to conduct two separate studies to assess the demand and supply situation, production scales, business models, mapping of supply chain, etc, for these products. The studies will be conducted to estimate not only for the domestic market but foreign as well.

According to officials, the government is keen to promote alternative medicine streams, mainly Ayurveda, which has picked up rapidly in the past few years. In fact, the Bharatiya Janata Party's election manifesto also emphasised and promised to promote the Ayurvedic drug industry.

However, the AYUSH industry still remains largely unorganised, with only a handful of big players selling branded products and doing business in international markets.

It is difficult to quantify the market for traditional Indian medicine systems, as many practitioners formulate and dispense their own recipes. Even so, annual turnover of products manufactured by large firms alone is estimated at $300 million a year. According to government estimates, there are about 700,000 registered AYUSH doctors across the country.

However, in the absence of proper standards, guidelines and regulatory mechanism, the industry has failed to gain credibility and make a mark in global markets, even as other nations like China have excelled. 

Source: Business-Standard