Indian pharma industry

Indian pharma industry needs to arm itself to be in perpetual audit mode. This is because of the new stringent global regulatory norms that are being enforced and the frequent inspections by the international regulatory enforcement teams, said Dr Vinay G Nayak, president, technical operations, Alembic Pharmaceuticals.

Since 2008, the US FDA issued 483s warning letters and imposed ban on production plants of Indian pharma companies following non adherence to quality standards and have put the sector under surveillance. The only way to gain confidence of the regulator, clear doubts and relax scrutiny would be to put in place systems to document practices, prevent microbial contamination of drugs, bring in reliability and integrity in procedures across laboratory and manufacturing systems, he added.

The way forward for a confident regulatory compliance would be to automate process of manufacturing, computerise lab operations, install surveillance systems across the facility to bring in transparency and accountability at all levels. There should be review of standard operating procedures versus practice, said Dr Nayak in his presentation on ‘Quality audit case studies- major quality issues and trends’, presented at the recently concluded IPA Platinum jubilee event.

BITTER PILL

India’s pharmaceutical industry may be considered as a defensive play in the stock markets as it is not subject to business cycles, but the sector is also going through a slowdown.

The Indian pharmaceutical market saw its pace of growth slowing to 9.8 per cent in 2013 from 16.6 per cent in 2012. According to a CII-PwC report —India Pharma Inc; changing landscape of Indian pharma industry — the slowdown is a result of the new drug pricing policy and the regulatory interventions over the past year.

 

While the growth rate declined after November last year from an average 16 per cent to 8 per cent, the sector showed a compounded annual growth rate (CAGR) of around 15 per cent from 2010 to 2012.

“This slowdown can be attributed to the national pharmaceutical pricing policy announced in 2012, higher growth in the corresponding previous quarters and the price corrections leading to low uptake among stockists in the second quarter of 2013 after the price policy was implemented.

Through the new policy, the government brought 348 drugs under price control from 74 earlier.

Both Indian and multinational companies were hit by the slowdown. However, the slowdown was more prominent among MNCs. In 2012, the top five MNCs had grown at the rate of 16 per cent, which fell to 7 per cent this year. The top five Indian companies saw their growth declining to 12 per cent in 2013 from 16 per cent in the previous year.

The number of new products introduced went down from around 1900 in 2010 to, approximately, 1700 in 2012. Of all the launches by April this year, the maximum were anti-infectives (468), pain-analgesics (435) and gastro (389) therapies.

 

Moreover, the sector was facing delays in clinical trial approvals. The government’s FDI policy has also sparked some confusion. The government allows 100 per cent FDI in greenfield investments under the automatic route. But since November 2011, brownfield investments require the approval of the FIPB.

CPhI Global Events - 2014

Well established pharmaceutical market with high quality drug standards. It is predicted to be worth US$ 90 billion by 2014. The generics sector is expected to increase their market share of sales from just over 8% in 2010 to almost 13% in 2015.

Pharmaceutical manufacturers and traders are urgently seeking to secure new and reliable suppliers of price-competitive and high-quality pharmaceutical ingredients. This trend is providing lucrative new business opportunities to international API suppliers. 

Alongside exhibiting pharmaceutical ingredients suppliers, companies with expertise in other sectors of the pharmaceutical industry are offering products and services at the co-located events of CPhI

CPhI – Japan	9 - 11 April 2014
CPhiI  - Russia	16 - 17 April 2014
CPhiI  - Southeast Asia	20 - 22 May 2014
CPhiI  - Istanbul	4 - 6 June 2014
CPhiI  and P-MEC China	26 - 28 June 2014
CPhiI  - South America	5 - 7 Aug. 2014
CPhiI  - Korea	2 - 3 Sep. 2014
CPhiI  and P-MEC India	2 - 4 Dec. 2014

CPhI provides you with excellent opportunities to:

• Generate new business and build successful relationships with key decision makers representing leading companies from all over the world.
• Expand your network and meet over 14,000 visitors and exhibitors.
• Get up-dated on the latest trends and developments within the pharma industry by participating in conferences, seminars and exhibitor presentations.
• Find all major suppliers of pharmaceutical ingredients, the latest machinery & technology, outsourcing solutions and bio-solution under one roof.