Cancer

WHO criticises big Indian supplier of tuberculosis drugs

WHO criticises big Indian supplier of tuberculosis drugs

WHO sounds alarm over big Indian supplier of tuberculosis drugsFemale Rogue Names

LONDON/MUMBAI (Reuters) – A major Indian supplier of tuberculosis

drugs to developing countries has been severely criticised by

the World Health Organization for inadequate manufacturing

standards and poor testing procedures.

The United Nations agency issued a warning letter to Mumba

i-based Svizera Labs, part of Maneesh Pharmaceuticals, stating

The move is the latest setback for India’s drugs industry, a vital source

of cheap generic medicines to countries worldwide which has been

tarnished by a series of quality problems.

Svizera is important well beyond India because it is one of four manufacturers

with a long-term contract to supply medicines to the Stop TB Partnership, a

WHO-backed organisation set up in 2001 to fight tuberculosis in more than 100 countries.

The WHO, which checks on medicines used by U.N. agencies,

Svizera Managing Director Vinay Sapte said he disagreed strongly with

the content of the report, adding that independent consultants who had v

Sapte said in an emailed statement.

SERIOUS CONCERNS

The lengthy list of deficiencies identified by the WHO team

included rusty and unclean surfaces on drug packaging lines

, defective seals and black mould in a cleaning area, generally l

ow hygiene standards, and inadequate factory record-keeping.

The inspectors also criticised the quality of drug testing and said

 

“The above examples raise serious concerns regarding the

integrity, reliability and accuracy of the data generated and available

at your manufacturing site and on your ability to prevent contamination

and cross-contamination of your products,” the letter stated.

Svizera will not be allowed to submit new products

said approvals would be suspended and it would recommend that agencies

stop buying from Svizera if the problems are not rectified within a reasonable time.

now part of SunPharmaceutical Industries.

clinical research organisation Quest Life Sciences.

WHO criticises big Indian supplier of tuberculosis drugs

WHO sounds alarm over big Indian supplier of tuberculosis drugs

LONDON/MUMBAI (Reuters) – A major Indian supplier of tuberculosis

drugs to developing countries has been severely criticised by

the World Health Organization for inadequate manufacturing

standards and poor testing procedures.

The United Nations agency issued a warning letter to Mumba

i-based Svizera Labs, part of Maneesh Pharmaceuticals, stating

The move is the latest setback for India’s drugs industry, a vital source

of cheap generic medicines to countries worldwide which has been

tarnished by a series of quality problems.

Svizera is important well beyond India because it is one of four manufacturers

with a long-term contract to supply medicines to the Stop TB Partnership, a

WHO-backed organisation set up in 2001 to fight tuberculosis in more than 100 countries.

The WHO, which checks on medicines used by U.N. agencies,

Svizera Managing Director Vinay Sapte said he disagreed strongly with

the content of the report, adding that independent consultants who had v

Sapte said in an emailed statement.

SERIOUS CONCERNS

The lengthy list of deficiencies identified by the WHO team

included rusty and unclean surfaces on drug packaging lines

, defective seals and black mould in a cleaning area, generally l

ow hygiene standards, and inadequate factory record-keeping.

The inspectors also criticised the quality of drug testing and said

 

“The above examples raise serious concerns regarding the

integrity, reliability and accuracy of the data generated and available

at your manufacturing site and on your ability to prevent contamination

and cross-contamination of your products,” the letter stated.

Svizera will not be allowed to submit new products

said approvals would be suspended and it would recommend that agencies

stop buying from Svizera if the problems are not rectified within a reasonable time.

now part of SunPharmaceutical Industries.

clinical research organisation Quest Life Sciences.

WHO criticises big Indian supplier of tuberculosis drugs

WHO sounds alarm over big Indian supplier of tuberculosis drugs

LONDON/MUMBAI (Reuters) – A major Indian supplier of tuberculosis

drugs to developing countries has been severely criticised by

the World Health Organization for inadequate manufacturing

standards and poor testing procedures.

The United Nations agency issued a warning letter to Mumba

i-based Svizera Labs, part of Maneesh Pharmaceuticals, stating

The move is the latest setback for India’s drugs industry, a vital source

of cheap generic medicines to countries worldwide which has been

tarnished by a series of quality problems.

Svizera is important well beyond India because it is one of four manufacturers

with a long-term contract to supply medicines to the Stop TB Partnership, a

WHO-backed organisation set up in 2001 to fight tuberculosis in more than 100 countries.

The WHO, which checks on medicines used by U.N. agencies,

Svizera Managing Director Vinay Sapte said he disagreed strongly with

the content of the report, adding that independent consultants who had v

Sapte said in an emailed statement.

SERIOUS CONCERNS

The lengthy list of deficiencies identified by the WHO team

included rusty and unclean surfaces on drug packaging lines

, defective seals and black mould in a cleaning area, generally l

ow hygiene standards, and inadequate factory record-keeping.

The inspectors also criticised the quality of drug testing and said

 

“The above examples raise serious concerns regarding the

integrity, reliability and accuracy of the data generated and available

at your manufacturing site and on your ability to prevent contamination

and cross-contamination of your products,” the letter stated.

Svizera will not be allowed to submit new products

said approvals would be suspended and it would recommend that agencies

stop buying from Svizera if the problems are not rectified within a reasonable time.

now part of SunPharmaceutical Industries.

clinical research organisation Quest Life Sciences.

WHO criticises big Indian supplier of tuberculosis drugs

WHO sounds alarm over big Indian supplier of tuberculosis drugs

LONDON/MUMBAI (Reuters) – A major Indian supplier of tuberculosis

drugs to developing countries has been severely criticised by

the World Health Organization for inadequate manufacturing

standards and poor testing procedures.

The United Nations agency issued a warning letter to Mumba

i-based Svizera Labs, part of Maneesh Pharmaceuticals, stating

The move is the latest setback for India’s drugs industry, a vital source

of cheap generic medicines to countries worldwide which has been

tarnished by a series of quality problems.

Svizera is important well beyond India because it is one of four manufacturers

with a long-term contract to supply medicines to the Stop TB Partnership, a

WHO-backed organisation set up in 2001 to fight tuberculosis in more than 100 countries.

The WHO, which checks on medicines used by U.N. agencies,

Svizera Managing Director Vinay Sapte said he disagreed strongly with

the content of the report, adding that independent consultants who had v

Sapte said in an emailed statement.

SERIOUS CONCERNS

The lengthy list of deficiencies identified by the WHO team

included rusty and unclean surfaces on drug packaging lines

, defective seals and black mould in a cleaning area, generally l

ow hygiene standards, and inadequate factory record-keeping.

The inspectors also criticised the quality of drug testing and said

“The above examples raise serious concerns regarding the

integrity, reliability and accuracy of the data generated and available

at your manufacturing site and on your ability to prevent contamination

and cross-contamination of your products,” the letter stated.

Svizera will not be allowed to submit new products

said approvals would be suspended and it would recommend that agencies

stop buying from Svizera if the problems are not rectified within a reasonable time.

now part of SunPharmaceutical Industries.

clinical research organisation Quest Life Sciences.

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