Indian Regulator DCGI to provide Written Confirmation certificate to Indian API exporters on submission of 6-month stability data

The Central Drugs Standard Control Organisation (CDSCO) will soon start issuing the mandatory Written Confirmation (WC) certificate to the Indian API exporters to European Union (EU) on providing the 6 months long term stability data against the earlier one-year period.

According to sources, the CDSCO has been getting recommendations from its zonal offices for grant of WC certificate wherein long term stability data and accelerated stability data submitted by the companies are lesser than the period of 12 months and six months respectively.

“The matter has been examined in detail. While renewing our commitment to the spirit of the GMP and also keeping in regard the international practices, it has been decided that applications containing 6 months accelerated and 6 months long term stability data on 3 batches and if no major changes from the specifications have been observed, issue of Written Confirmation certificate to such APIs would be considered”, Drugs Controller General of India (DCGI) Dr GN Singh said.

For this, the DCGI has put forward two conditions. One, the firm should submit the stability protocol among with the undertaking or a stability commitment that an ongoing stability programme is in place and they shall submit the data covering the retest periods/shelf life of the API within 30 days on completion of the studies to the concerned CDSCO zonal office.

Second, the firm should assign retest/expiry date of the API based on available stability data as per the procedure laid down in the ICH Guidelines. The firm should provide a commitment regarding the retest period/shelf life of the API.

The EU had mandated through its Directive No 2001/83/EC dated 8th June, 2011 that every consignment of API from non-EU/non-listed countries must be supported by a Written Confirmation (WC) certificate issued by the competent authority of that country, stating that the consignment conforms to the standards of GMP as laid down in the EU guidelines or equivalent thereof. This became effective from July 2, 2013.

The EU Directive is aimed at preventing falsified medicinal products from entering EU from other countries.

Health Canada restrict import of products from three Micro Labs facilities in India...

Health Canada took action today to restrict the import of health products from three Micro Labs facilities in India (Bangalore, Goa and Hosur) because of data integrity concerns identified in recent inspections by international partners.

Health Canada has compiled a list of products affected by the import restrictions. The list will be updated as new information becomes available.

The licences of companies that import products from these three facilities will be amended with terms and conditions to require independent third-party testing prior to the release of any products determined to be medically necessary onto the Canadian market. Products from these three sites that are not on the medically necessary list will not be allowed to beimported or released on to the Canadian market until Health Canada is satisfied that the data integrity issues at the plants have been addressed.

Independent testing against approved Canadian specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.

Health Canada continues to gather information about the situation at these sites from trusted international partners, including the U.S Food and Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the World Health Organization. Based on a review of this information, the Department has significant concerns with the manner in which data are collected and reported, raising uncertainty about the quality and safety of products from these sites. Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognized good manufacturing practices (GMPs), it is taking this additional precautionary step to keep these products off the Canadian market.

India - CDSCO - Updated List of FDCs (Fixed-Dose-Combinations) Approved for Marketing in India

India’s National Drug Authority, Central Drugs Standard Control Organization (CDSCO) has updated list of approved FDCs (Fixed-Dosed-Combinations Drugs) approved for marketing in India.

A detailed list of these Fixed Dosed Combination Drugs up to July 2014, have been attached here for reference.

Please CLICK HERE to view/download list of approved FDCs (Fixed-Dosed-Combinations Drugs) approved for marketing in India

Strides Arcolab buys Shasun Pharma for $ 200 Million in an all-stock deal...

 

Webcast of Investor Meet - September 30, 2014

USFDA continues to audit Sun Pharma's Halol Plant for more than 11 days...

India-based Sun Pharmaceutical Industries Ltd., have faced 11-day long regulatory audit from USFDA, where inspecters have taken a break only on sunday, and expects to end the audit soon.

The USFDA have conducted surprise audits at Sun Pharma's Halol Plant which was started on Sept 8, is still in continuation as on Sep 19. Close sources said, three USFDA inspectors are still at halol facility and are focusing on sterile units and microbiology labs.

They also added that USFDA inspectors brifly inspected manufacturing processes and have focused on the quality control labs. FDA is concentrating to assess data and records primarily in the HPLC site and micro data site.

Major issues USFDA noted are the same as seen in previous cases like incomplete records, concurrent data mismatch, non-maintenance of records etc. These observations in the past have been treated as adverse observations. But here in this case everything will clear only once audit completed.

However a 11 days surprise audit and a list of observations might raise a Form 483, but it only a assumption at this point of time.

Generally, USFDA issues a form 483 with its observations at the end of the audit, giving the company a timeframe to rectify any observations.

Sun Pharma’s Halol Plant contributes 25% of company’s profitability.

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.

Health Canada requests quarantine of products from IPCA Laboratories following falsification and manipulation of data issues...

Health Canada has taken the precautionary step of asking IPCA Laboratories in India to voluntarily stop shipment of products to Canada based on a review of a recent good manufacturing practices (GMP) inspection report by the U.S. Food and Drug Administration (FDA) where they identified falsification and manipulation of data issues at the company. IPCA has not disputed the FDA findings with Health Canada. The FDA has not issued a recall of any of the affected products.

Health Canada estimates that this affects approximately 21 active pharmaceutical ingredients (APIs). The Department has also asked Canadian companies that import product containing APIs from the IPCA facilities to temporarily quarantine these products.

To date, there has been no indication that the issues identified during the FDA inspection pose a risk to health. Therefore, like the FDA, Health Canada is not requesting a recall of products already on the market. If the situation changes, the Department will take immediate action and inform Canadians.

The information being sought includes any additional testing being done, the medical necessity of the products involved, their market share, and risk assessments. This process will likely take a few weeks to complete given the complexity of efforts. At this time, we do not expect that there will be an immediate impact on the availability of these products. The Department will work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies.

Health Canada has requested that the voluntary quarantine continue until the Department is satisfied that adequate measures are in place to confirm the quality of the products from these facilities and protect the health and safety of Canadians.

For Detailed Information CLICK HERE

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