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Big Pharmas regret costly Indian collaboration deals

Hello Götterdämmerung:oops: (Plz change with any short or easy pronounceable name for PDF only)

For Pharma try this link URL 'http://www.cdsco.nic.in/' and
this URL 'http://www.nistads.res.in/indiasnt2008/t4industry/t4ind18.htm'
 
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There are no separate state laws for Pharmaceuticals or food products.

For starters, check out the links for laws, rules and regulations here:

Indian Pharmaceutical Association

That's the exact answers I tried to find. Weird that I have found them in a military forum. :lol:

Big thanks!

PS: It seems you are familiar with this matter (I'm a journalist), is there also an Indian specific forum like ifsqn.com?
 
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It will be a very good day if the foreign companies leave their acquired Indian pharmaceuticals companies. :tup:

The no. 1 and no 2 biggest Indian pharmaceutical companies are acquired by foreigners as a result there is a danger of foreign players dominating Indian pharma sector, they will benefit from our hard work.

And Indians will have to pay higher prices for medicines as the foreign companies charges very high rate for the same drugs, till today Indian market is dominated by Indian pharma companies and they are providing best medicines at a affordable rates.

This is the same reason that Indian companies have given representation to the govt. to ban more then 49% stake buy in Indian companies but manmohan singh is under US pressure and don't want to hurt his image of economic liberalization. :hitwall:


Pharma Industry Should be Protected From Foreign Takeover | Socyberty

Pharma FDI cap may be cut to 49% - Times Of India
 
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Götterdämmerung;2468315 said:
That's the exact answers I tried to find. Weird that I have found them in a military forum. :lol:

Big thanks!

PS: It seems you are familiar with this matter (I'm a journalist), is there also an Indian specific forum like ifsqn.com?
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Sorry this one!!!

For food Safety check this 'http://www.fssai.gov.in/'
 
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Pharma FDI cap may be cut to 49%

NEW DELHI: An inter-ministerial group ( IMG) has suggested that foreign direct investment (FDI) cap in existing pharmaceutical ventures be lowered to 49% from 100% to check takeover of local companies by multinationals, :tup: a move which has now been referred for a second opinion to the Planning Commission amid protests from foreign players. :lol:

Sources in the government told TOI the panel comprising representatives from the health ministry and pharmaceuticals and industry departments had recommended that in case of brownfield ventures, not only should FDI be capped but these investments should also be approved by the government.

At present, companies only need to inform RBI if they are investing in an Indian company. The panel, set up following protests from the domestic industry, has said that the present system of 100% FDI through the automatic route be retained for greenfield ventures. This is the first instance of the government reducing the sectoral FDI ceiling to protect domestic interest groups—something that it had refrained from doing in the first 20 years of reforms though there was a strong demand from the pro-swadeshi lobby.

The decision in this case has been triggered by concerns that the government would be unable to pursue its policy of affordable medicine and may find it tough to use manufacturing facilities in the country to cope with epidemics and health emergency.

In recent years, several Indian pharma companies have been acquired by global giants. The list includes Japan's Daiichi acquiring control of Ranbaxy, the stake sale by the Piramals to Abbot, acquisition of Shanta Biotech by Sanofi Aventis, Orchid Chemicals by US-based Hospira and Matrix Labs by Mylan Inc.

Though the committee's decision, which has also been conveyed to the finance ministry, came several weeks ago, sources said it was surprising that the matter was referred to the Planning Commission when it is neither involved in FDI policy formulation nor is it entrusted with approvals. Sections within the government also hinted at the possibility of pharma multinationals lobbying with pro-reform elements within UPA to stall the proposal.

When asked, Planning Commission deputy chairman Montek Singh Ahluwalia told TOI that the move to review IMG's decision followed discussions in the Cabinet. He said a view was yet to emerge and the issue was only being discussed by a committee to be headed by plan panel member Arun Maira.

Sources within the government, who complained of delay in decision making, said Maira, the former India head of Boston Consulting Group, was entrusted with the task nearly two months ago but is yet to hold a meeting. Novartis president Ranjit Shahani, who is president of the OPPI, a lobby group representing multinational drug companies, termed the proposal "retrograde" though he confirmed meeting functionaries in ministries of health, commerce and the Planning Commission for what he termed "advocacy". "It (a cut in FDI cap) will have a chilling effect on FDI in the country," he said. "FDI should not stand for funds deserting India."

OPPI has argued that the government has tools available to address concerns raised by domestic players and civil society groups. Indian players have a different take. Indian Pharmaceutical Alliance secretary general D G Shah said in 2001, when the government issued a press note allowing 100% FDI under the automatic route, it had put in place two conditions related to transfer of technology and investment in manufacturing.

Pharma FDI cap may be cut to 49% - Times Of India
 
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For food Safety check this 'http://www.cseindia.org/taxonomy/term/7607'

Thanks a lot, will need some times to go through all the links you and gubbi gave me. :)
 
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I thooght Indian pharma industry was one of the biggest in the world, with decent reputation that even our Chinese friends started faking 'made in India'drugs to sell in Africa and other developing countries.
 
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Götterdämmerung;2468284 said:
Sorry, I was not clear, I was looking for state laws where GMP and HACCP is positionned. Something like EC-Order 852/2004 for EU and FD&C Act Chapter IV, 21 CFR Parts 808 for the US. I want to know which paragraph states that GMP and HACCP should be implemented.

But thanks for the links anyway.

There are no separate state laws for Pharmaceuticals or food products.

For starters, check out the links for laws, rules and regulations here:

Indian Pharmaceutical Association


Who told u that ?????????

Ever heard of :

1. "The Food Safety and Standards Act, 2006"???????

2. The Central Drug Standards and Control Organization (CDSCO), located under the aegis of the Ministry of Health and Family Welfare.

The CDSCO prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country; regulates the market authorization of new drugs and clinical trials standards; supervises drug imports and approves licences to manufacture the above-mentioned products.

The Department of Chemicals and Petrochemicals also oversees policy, planning, development and regulatory activities pertaining to the chemicals, petrochemicals and pharmaceutical sector. The responsibilities assumed by this body are relatively broader and varied in comparison to the other two bodies. The main aspects of pharmaceutical regulation are thus divided between the above two ministries. The Ministry of Health and Family Welfare examines pharmaceutical issues within the larger context of public health while the focus of the Ministry of Chemicals and Fertilizers is on industrial policy. However, other ministries also play a role in the regulation process. These include the Ministry of Environment and Forests, Ministry of Finance, Ministry of Commerce and Industry and the Ministry of Science and Technology. The process for drug approval entails the coordination of different departments, in addition to the DCGI, depending on whether the application in question is for a biological drug or one based on recombinant DNA technology. Issues related to industrial policy such as the regulation of patents, drug exports and government support to the industry are governed by the Department of Industrial Policy and Promotion and Directorate General of Foreign Trade, both under the aegis of Ministry of Commerce and Industry and the Ministry of Chemicals and Fertilizers. With respect to licencing and quality control issues, market authorization is regulated by the Central Drug Controller, Ministry of Health and Family Welfare, Department of Biotechnology, Ministry of Science and Technology (DST) and Department of Environment, Ministry of Environment and Forests. State drug controllers have the authority to issue licences for the manufacture of approved drugs and monitor quality control, along with the Central Drug Standards Control Organization (CDSCO).


t4ind18_fig0.JPG


GMP is mandatory in India and in India there are largest number of US FDA approved facilities in the world (Outside USA).

The requirements specified under the upgraded Schedule ‘M’ for GMP have become mandatory for pharmaceutical units in India w.e.f. July 1, 2005. Schedule M classifies the various statutory requirements mandatory for drugs, medical devices and other categories of products as per the current Good Manufacturing Practices (cGMP). Schedule M protocols have been revised to harmonize it along the lines of WHO and US-FDA protocols. These revised protocols include detailed specifications on infrastructure and premises, environmental safety and health measures, production and operation controls, quality control and assurance and stability and validation studies.

 
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Götterdämmerung;2468315 said:
That's the exact answers I tried to find. Weird that I have found them in a military forum. :lol:

Big thanks!

PS: It seems you are familiar with this matter (I'm a journalist), is there also an Indian specific forum like ifsqn.com?


I worked for Ranbaxy, before and Daichy take over. We were service provider for Ranbaxy or O&M of plant & utilities. Manufacturing facility, where i was looking after is one from two FDA banned facilities:P.

I can assure that quality standards were & are very high there. Ranbaxy plant management was very strict at implementation of FDA/MHRA/GMP regulation. As for as i know, it was some documentation messed up by some ousted employee.
 
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I worked for Ranbaxy, before and Daichy take over. We were service provider for Ranbaxy or O&M of plant & utilities. Manufacturing facility, where i was looking after is one from two FDA banned facilities:P.

I can assure that quality standards were & are very high there. Ranbaxy plant management was very strict at implementation of FDA/MHRA/GMP regulation. As for as i know, it was some documentation messed up by some ousted employee.

Cool, so you are an expert! LOL, never though to find an Indian GMP expert in a Pakistani military forum. This world is weird, indeed! :lol:

In my research I had no difficulties finding tons of fact from the EU, China was surprisingly easy to get all the relevant facts. The US also has lots of facts, but I couldn't find any GMP in practice, e.g. company XYZ produces product ABC and the GMP/HACCP they use looks like that. Particularly in the sterile drugs and devices. Do you happen to know whether there is any public document like that in India on the internet?

Thanks in advance!
 
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Götterdämmerung;2468511 said:
In my research I had no difficulties finding tons of fact from the EU, China was surprisingly easy to get all the relevant facts. The US also has lots of facts, but I couldn't find any GMP in practice, e.g. company XYZ produces product ABC and the GMP/HACCP they use looks like that. Particularly in the sterile drugs and devices. Do you happen to know whether there is any public document like that in India on the internet?

Apart from the govt mandatory regulations, the SOPs and GMPs are company proprietary documents. I doubt you would find such 'sensitive' documents in public domain.

Btw, I trained as a Pharmacist, hence the 'familiarity'. :)
 
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Hello Götterdämmerung:oops: (Plz change with any short or easy pronounceable name for PDF only)

For Pharma try this link URL 'http://www.cdsco.nic.in/' and
this URL 'http://www.nistads.res.in/indiasnt2008/t4industry/t4ind18.htm'

Twilight of the Gods!
 
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Apart from the govt mandatory regulations, the SOPs and GMPs are company proprietary documents. I doubt you would find such 'sensitive' documents in public domain.

Btw, I trained as a Pharmacist, hence the 'familiarity'. :)

I have found the GMP of Coca Cola online, but no pharmacy for the US. In the EU both were available online.

Oh, IC. that's a good profession! :)
 
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Who told u that ?????????

I was replying to a query about separate States' individual laws for Pharmaceuticals or Food products. In India its all under the Cental Drugs Control Authority - CDSCO.
 
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Götterdämmerung;2468681 said:
I have found the GMP of Coca Cola online, but no pharmacy for the US. In the EU both were available online.

Oh, IC. that's a good profession! :)


Götterdämmerung = Twilight of the Gods!!!! Its nice one!

Gott, do you need cGMPs being used in Indian Pharma Industry???? if yes, pm me ur e-mail id, i wl see hw much i can help!!!

I am not an expert in pharma regulatory affairs, i was in maintenance & it is more to do with QA/QC departments. But i worked with engineers from Belgium, Swiss and UK working for different GEA GROUP companies like BUCK, NERO & COLETTE etc. as a team member to setup a new production facility. Thats why i have some information about pharma (Both API & Formulation) regulatory requirements. cGMPs for equipment might also be available at GEA GROUP websites.
 
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