Pharmabiz
 

Pharmexcil initiatives to forge closer ties with USFDA

Our Bureaus, Hyderabad, MumbaiThursday, April 14, 2016, 08:00 Hrs  [IST]

The Pharmaceuticals Export Promotional Council of India (Pharmexcil) initiative to build closer relations with USFDA officials is bearing fruits. After the council’s recent meet with the Mathew T Thomas, Director USFDA, India in Hyderabad, a three member team from India visited USA for further interactions with Dr. Robert Cliff, Managing Director and commissioner of USFDA.

“We have had a fruitful meeting with senior drug regulators. To further improve close relations with USFDA regulators we met with Dr. Robert Cliff from USFDA and other regulators and chalked out plans to organize workshops between officers of USFDA and Indian regulators and industry players for mutual understandings and improve standards for drug development,” informed Dr. Appaji, Director General of Pharmexcil.

Key members of the visiting team from India to USA included members from office of DCGI, Sudhanshu Pandey, Joint Secretary from Ministry of Commerce and Dr. P.V. Appaji. Major interactions with USFDA officials focused on understanding the needs of USFDA regulators. “Major issues that had come for discussion is to share data for enabling better understanding of US requirements and leverage services from Indian exporters as per their needs,” said Appaji.

With this interaction, council has got recognition from the USFDA drug regulator as an important agency of the government for reliable information about the pharma manufacturing both small and big in India. “They have asked to share data about pharma industry, both small and big manufacturing various drug products and exports. It is a mutual sharing and understanding initiative which will continues for a long time for better understanding of both sides and improve our business relations,” observed Dr. Appaji.

With further collaboration with USFDA, the Pharmexcil is planning to organize two programmes in a year between regulators and industry. Focus of these interactive programmes would be to train the industry executives by the USFDA regulators on different requirements as well as understand and deliver services as per regulatory needs of the USFDA. This would make the Indian exporters more acquainted with the changing regulatory norms from time to time and avoid any misunderstandings.

“Our endeavour with USFDA and other regulators across the world is to make Indian pharma exporters more robust and help them understand the changing regulatory norms from time to time. This is will also give us an opportunity to learn new things and improve our manufacturing standards and capability to supply the global markets,” said Appaji, while explaining the council’s major agenda for regulatory tie ups USFDA.

In the meanwhile, according to a Pharmabiz study, the year 2015 was marked by significant higher US FDA approvals for ANDAs as compared to steady decline in approvals during the last couple of years. The USFDA approved total 564 ANDAs in 2015 as compared to 385 ANDAs in 2014 and 400 ANDAs in 2013. The ANDA approvals went up sharply by 46.5 per cent during 2015 as compared to declined of 3.8 per cent in 2014 and 16 per cent in 2013.

With higher investments in R&D expenditure and focus on new product launches, Indian pharmaceutical majors and their subsidiaries secured 167 ANDA approvals in 2015 as compared to 130 ANDAs and 154 ANDAs in 2014 and 2013 respectively. Indian companies registered strong growth of 28.5 per cent in ANDA approvals as compared to decline of 15.6 per cent in 2014 and 13.5 per cent in 2013. However, the percentage of India pharma companies in total approvals declined in 2015 to 29.6 per cent from 33.8 per cent in 2014 and 38.5 per cent in 2013 may be due to warning letters issued to several Indian players in last few years.

The tentative approvals by USFDA also increased by 47 per cent in 2015 to 147 approvals from 100 approvals in 2014 and 86 approvals in 2013. Indian companies received 48 tentative approvals during 2015 as against 100 tentative approvals in 2014 and 86 approvals in 2013.

A Pharmabiz study of leading 25 companies showed that these companies have created strong product pipeline by filing ANDAs, DMFs and patents in the world market.

Aurobindo Pharma,fourth largest Indian pharmaceutical company by sales of Rs.12,000 crore, has secured the highest number of ANDA approvals during 2015 and it got total 33 ANDA approvals. Lupin, the third largest pharma company, received approvals for 29 ANDAs. Macleods Pharma, a Mumbai based unlisted pharma major with presence in more than 80 countries, has received 12 ANDA approvals from US FDA in 2015. Jubilant Generics, Alembic Pharma, Glenmark Pharmaceuticals and Hetero Labs received more than 10 ANDA approvals each. Sun Pharmaceuticals and Torrent Pharma secured 8 ANDA approvals each.

As at the end of December 2015, Aurobindo has a total of 252 ANDA approvals (216 final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.

Lupin's revenue expenditure on R&D during the first nine months ended December 2015 increased to Rs.1,093 crore from Rs.789 crore in the previous year, a strong growth of 38.5 per cent. The company received ANDA approvals for 29 ANDAs in 2015 as compared to 13 ANDAs in the previous year. Glenmark Pharmaceutical filed 6 ANDA applications with the US FDA during the first nine months ended December 2015 and it intends to file another 6-8 ANDA applications in the current quarter.

For the first quarter ended March 2016, USFDA approved 151 ANDAs and out of this Indian companies grabbed 50 ANDA approvals. Similarly, US FDA approved 36 tentative approval for ANDAs and Indian companies secured 19 tentative approvals. Thus, the R&D investments by Indian pharma companies are well set to push more approvals from USFDA in the current year.

Earlier an ICRA research study had pointed out that the Indian pharmaceutical segment is passing through challenging situation on account of issuance of warning letters and import alerts to the leading companies by USFDA. Greater scrutiny by USFDA is emerging as a key challenge for Indian pharmaceutical sector and such regulatory actions are holding potential to delay product approvals and launches in the US.

According to ICRA , in an environment where companies are going through pricing pressure owing to increased competitive intensity, these development are likely to add to margin pressures. Nonetheless, it is believed that the credit profile of affected entities is unlikely to be impacted in view of their strong balance sheets and liquidity. During 2015, USFDA issued 17 warning letter against seven in the 2014 and major companies like Dr Reddy's Laboratories, Cadila Healthcare, Sun Pharmaceutical, Unimark Remedies, Micro Laboratories were recipient of warning letters or import alerts during 2015. Earlier, Wockhardt, Ranbaxy, Jubilant Life, Aarti Drugs, USV Ltd, etc also received warning letters.

Inadequate systems and controls to prevent alteration in laboratory test results and associated documentation, slippages with respect to adherence of cGMP guidelines during R&D, validation and manufacturing stages, and absence of robust manpower training programmes and management systems were the common reasons that have actually prompted USFDA to take regulatory action.

As a result of USFDA's stringent follow up on manufacturing standards, pharma companies are now mandated to review their R&D and manufacturing procedures, implement comprehensive action plans and even conduct risk assessment of products that are already in the market. Based on the severity of the deviations, the FDA has also directed some companies to get third-party evaluation of their remediation processes. In addition, companies have also been taking site transfer (especially for major launches) and pursuing filings from dual locations for future ANDAs. These measures are likely to entail significant resources and impact earnings of select companies in the near-term, the report had pointed out.

 
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