Foreign Policy: India is flooding the world with tainted drugs.

[[Bregs]]

Very misleading thread

 

[[Bregs]]

HYDERABAD: Pharmaceutical exports from India is expected to remain in the range of 10 to 11 per cent in the current fiscal as slowdown in some of the key markets such as North America and Europe continue to cause concern to exporters, a senior government official said.


P V Appaji, Director General of Pharmaceuticals Export Promotion Council (Pharmexcil), under the Ministry of Commerce and Industry, said most of the Indian pharma exporters have secured written confirmation (WC) certificates from the Drug Controller General of India well in time to meet the new European Union (EU) regulations on active pharmaceutical ingredients (API) imports.


"This year, there is a slowdown (in some markets). We are looking anxiously. We will have to still ascertain the position. More or less it (pharma exports growth) can be in the same range. The exact position would be clear in the next few days," Appaji told PTI.

The growth of Indian pharma exports during 2012-13 halved to 10.55 per cent over previous year to $ 14.6 billion. During 2011-12 the exports stood at $ 13.2 billion registering a growth of 23.7 per cent over 2010-11.

Major markets for Indian pharma exports USA and Europe underperformed during FY13 causing a big dent to exports.

While exports to North America grew 13.44 per cent to $ 4 billion, exports to Europe grew marginally by just 1.2 per cent to $ 2.63 billion. A year-ago, exports to North America and Europe registered a growth of 33 per cent and 30 per cent, respectively.

"There was some business loss from USA and Europe markets. Last two to three years US market growth was good. By the year end we expect that the USA market will become normal," Appaji added.

Echoing similar views, Sarabjit Kour Nangra, VP Research Specialist pharmaceuticals, Angel Broking, said the industry is expected to do well in terms of exports to USA this year.


"None of the companies we are tracking with have expressed any apprehensions over exports. More or less it should be healthy growth," Nangra said.

On the new EU Regulation on API exports, Appaji said as many as 170 companies have secured WC certificates in time and there is no hindrance in exports.

The European Medicines Agency in its directive said effective 2 July 2013, all active substances manufactured outside of the EU and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country.

The concerned authority would confirm that the standards of good manufacturing practice (GMP) and control of the manufacturing plant are at par with those in the EU.

In case of India, Drug Controller General of India is the competent authority to issue WC, Appaji said.

"DCGI is the notified competent authority for certification of goods. Pharmexcil has followed up with the DCGI in preparing guidelines and circulate it to member companies," he said.

As per the guidelines, the industry is submitting applications and zonal offices of DCGI are examining the applications and forwarding them to the main office.

US, EU slowdown may keep pharma export growth at 10%: Official - Economic Times


India: new strategy to boost pharma exports



India has announced plans for a new short-term strategy aimed at boosting pharmaceutical exports, and has also set guidelines for domestic drugmakers to comply with a European Union (EU) directive on imports of bulk drugs into Europe.

The new initiative to encourage drug exports is being introduced because of government concern over their slow pace of growth in US dollar terms. It has become clear that the target set for exports of pharmaceuticals to have reached at least $25 billion by March 2014 will be difficult for the industry to achieve, and the strategy will be put in place to help enable the sector to achieve this goal by March 2015, according to the Pharmaceutical Export Promotion Council of India (Pharmexcil), an agency of the Commerce and Industry Ministry.

During 2012-13, India's exports of pharmaceuticals increased in local currency terms by 25% to reach 80,000 crore rupees. However, when expressed in US dollars, exports for the year amounted to £14.5 billion, representing an annual rise of 9%, which is a considerable drop from the 22% dollar-terms growth reported two years earlier, says Pharmexcil.

After reviewing the sector's export performance, "it is noted that the target figure of $25 billion exports would be difficult to achieve by the projected timeline of March 2014. In order to ensure achievement of the targeted $25 billion at least by March 2015 (one year later), the Ministry is keen to develop a short-term strategy plan," said the agency in a statement.

Meantime, the government has also announced new guidelines for drugmakers to comply with an EU directive on Good Manufacturing Practice (GMP) standards for active pharmaceutical ingredients (APIs) imported into the EU.


The directive was issued on June 8, 2011 and comes into force on July 2. After that date, India will be required to certify that locally-made APIs being imported into the EU comply with European quality standards. At present, such certification is carried out by the importing nation.

The new legislation will require written confirmation by a competent authority nominated by the Indian government that the API has been manufactured in accordance with EU GMP standards. The authority will also give written confirmation that the facility where the API is produced is subject to control and enforcement of GMP standards and that it is equivalent to those in EU member states.

"Various EU industry members have been expressing their concern about the ability of India to comply with the new procedure by the deadline of July 2, 2013. However, the government of India is optimistic that its pharma industry would be able to meet regulatory requirements within the given timeframe," according to a statement issued by the Ministry.

"India has demonstrated its keenness to meet international requirements for exports of pharmaceutical products yet again by taking timely action for complying with the new procedural requirements of the EU," the statement adds.
Links

Article > India: new strategy to boost pharma exports

 

[IND151]

HYDERABAD: Pharmaceutical exports from India is expected to remain in the range of 10 to 11 per cent in the current fiscal as slowdown in some of the key markets such as North America and Europe continue to cause concern to exporters, a senior government official said.


P V Appaji, Director General of Pharmaceuticals Export Promotion Council (Pharmexcil), under the Ministry of Commerce and Industry, said most of the Indian pharma exporters have secured written confirmation (WC) certificates from the Drug Controller General of India well in time to meet the new European Union (EU) regulations on active pharmaceutical ingredients (API) imports.


"This year, there is a slowdown (in some markets). We are looking anxiously. We will have to still ascertain the position. More or less it (pharma exports growth) can be in the same range. The exact position would be clear in the next few days," Appaji told PTI.

The growth of Indian pharma exports during 2012-13 halved to 10.55 per cent over previous year to $ 14.6 billion. During 2011-12 the exports stood at $ 13.2 billion registering a growth of 23.7 per cent over 2010-11.

Major markets for Indian pharma exports USA and Europe underperformed during FY13 causing a big dent to exports.

While exports to North America grew 13.44 per cent to $ 4 billion, exports to Europe grew marginally by just 1.2 per cent to $ 2.63 billion. A year-ago, exports to North America and Europe registered a growth of 33 per cent and 30 per cent, respectively.

"There was some business loss from USA and Europe markets. Last two to three years US market growth was good. By the year end we expect that the USA market will become normal," Appaji added.

Echoing similar views, Sarabjit Kour Nangra, VP Research Specialist pharmaceuticals, Angel Broking, said the industry is expected to do well in terms of exports to USA this year.


"None of the companies we are tracking with have expressed any apprehensions over exports. More or less it should be healthy growth," Nangra said.

On the new EU Regulation on API exports, Appaji said as many as 170 companies have secured WC certificates in time and there is no hindrance in exports.

The European Medicines Agency in its directive said effective 2 July 2013, all active substances manufactured outside of the EU and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country.

The concerned authority would confirm that the standards of good manufacturing practice (GMP) and control of the manufacturing plant are at par with those in the EU.

In case of India, Drug Controller General of India is the competent authority to issue WC, Appaji said.

"DCGI is the notified competent authority for certification of goods. Pharmexcil has followed up with the DCGI in preparing guidelines and circulate it to member companies," he said.

As per the guidelines, the industry is submitting applications and zonal offices of DCGI are examining the applications and forwarding them to the main office.

US, EU slowdown may keep pharma export growth at 10%: Official - Economic Times


India: new strategy to boost pharma exports



India has announced plans for a new short-term strategy aimed at boosting pharmaceutical exports, and has also set guidelines for domestic drugmakers to comply with a European Union (EU) directive on imports of bulk drugs into Europe.

The new initiative to encourage drug exports is being introduced because of government concern over their slow pace of growth in US dollar terms. It has become clear that the target set for exports of pharmaceuticals to have reached at least $25 billion by March 2014 will be difficult for the industry to achieve, and the strategy will be put in place to help enable the sector to achieve this goal by March 2015, according to the Pharmaceutical Export Promotion Council of India (Pharmexcil), an agency of the Commerce and Industry Ministry.

During 2012-13, India's exports of pharmaceuticals increased in local currency terms by 25% to reach 80,000 crore rupees. However, when expressed in US dollars, exports for the year amounted to £14.5 billion, representing an annual rise of 9%, which is a considerable drop from the 22% dollar-terms growth reported two years earlier, says Pharmexcil.

After reviewing the sector's export performance, "it is noted that the target figure of $25 billion exports would be difficult to achieve by the projected timeline of March 2014. In order to ensure achievement of the targeted $25 billion at least by March 2015 (one year later), the Ministry is keen to develop a short-term strategy plan," said the agency in a statement.

Meantime, the government has also announced new guidelines for drugmakers to comply with an EU directive on Good Manufacturing Practice (GMP) standards for active pharmaceutical ingredients (APIs) imported into the EU.


The directive was issued on June 8, 2011 and comes into force on July 2. After that date, India will be required to certify that locally-made APIs being imported into the EU comply with European quality standards. At present, such certification is carried out by the importing nation.

The new legislation will require written confirmation by a competent authority nominated by the Indian government that the API has been manufactured in accordance with EU GMP standards. The authority will also give written confirmation that the facility where the API is produced is subject to control and enforcement of GMP standards and that it is equivalent to those in EU member states.

"Various EU industry members have been expressing their concern about the ability of India to comply with the new procedure by the deadline of July 2, 2013. However, the government of India is optimistic that its pharma industry would be able to meet regulatory requirements within the given timeframe," according to a statement issued by the Ministry.

"India has demonstrated its keenness to meet international requirements for exports of pharmaceutical products yet again by taking timely action for complying with the new procedural requirements of the EU," the statement adds.
Links

Article > India: new strategy to boost pharma exports

Thanks for info

 

[[Bregs]]

India to join PIC/S to safeguard drug exports

Updated on 5 September 2013


India is considering joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme to safeguard its drug exports Currently, 43 drug importing countries are a part of the global forum called ‘Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme’ Related Articles South Korean drug firms look overseas for profit GMP violation leads US FDA to warn two Indian firms Drug delivery: 11 technologies of the future India bans pain killer 36 years after the US did so Singapore: India is mulling over joining a global forum that currently has 43 drug importing countries to ensure safety of drug exports. The forum, officially titled ‘Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme' (PIC/S) has the US and the European Union among its key members. As per the agreement of this forum, drug regulators of member countries ensure compliance with standards rather than individual manufacturers. The looming fear of India's drug exports suffering in the medium-to-long term is the reason the country is considering this. "It is going to impact our export growth as more and more countries are now looking for PIC/S compliance. India should join the league at the earliest," said Mr PV Appaji, director general, Pharmaceuticals Export Promotion Council (Pharmaexcil), India. Further, the country's Commerce Ministry recently initiated a discussion with officials of the Drugs Controller General of India (DCGI) and the health ministry to examine the likely impact of joining the forum. "As there is the requirement that the whole pharma industry, including non-exporters, be compliant with the standards, the issue needs to studied more carefully," Mr Sudhanshu Pandey, joint secretary, ministry of commerce, opined. India currently has the highest number of US FDA approved manufacturing facilities in the world, apart from the US. This is the main reason the country's pharma industry fears losing drug exports to other emerging generic producing nations. India's pharma industry exports grew to $14.5 billion during 2012-13, up from $13.2 billion the previous year.


Read more at: India to join PIC/S to safeguard drug exports - BioSpectrum Asia

 

[IND151]

Disgusting cheaters!

We should ban all Indian products from entering our markets.

I don't want medicines from 3rd world countries like India that give me more problems.

Give me a break, we aren't forcing anyone to do business with us.

As if China is buying these medicines just to be friendly with India

Chinese consumers choose the most competitively priced product to get the most value.

Nobody deals with India to do us a favour. They do it because we offer the most competitive deal for them, they CHOOSE to deal with us.

We aren't forcing anyone to trade with us.

People deal with us because they see a benefit to themselves.
@nick_indian @Roybot @Chinese-Dragon

If they don't like the deal for whatever reason, they can go and deal with someone else.

 

[Guynextdoor2]

Yeah...Indian pharma has a real big problem. We need a strong regulator for pharma (just like we have for IT and other industries)

 

[MULUBJA]

Yes and that's why the world is not buying any Indian BAD medicine anymore !!!

If world is not buying Indian Drugs than where is the question of flooding the world with tainted drugs?

 

[dray]

Disgusting cheaters!

We should ban all Indian products from entering our markets.

I don't want medicines from 3rd world countries like India that give me more problems.

Indian medicines are good enough for you; considering the fact that the other option you have is Chinese medicines laced with cancer causing toxic substances.