US Food and Drug Administration (FDA) has taken certain regulatory actions in respect of violations or deviations of US FDA regulations applicable in that country in the cases of the following Indian Pharmaceutical companies:-
1. M/s Ranbaxy Laboratories Ltd.,
2. M/s Wockhardt Ltd.,
3. M/s Hospira Healthcare India Pvt. Ltd.,
4. M/s RPG Life Sciences Ltd.,
The Drugs Controller General (India) [DCG(I)] has taken appropriate measures to ensure that the said firms manufacture drugs in compliance with the standards and Good Manufacturing Practices prescribed for them under the Drugs and Cosmetics Rules, 1945 through the system of inspections and testing of drugs.
This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the LokSabha today
DCGI asked to check quality of drugs sold by Ranbaxy: Govt
The government has ordered the Drug Controller General of India (DCGI) to check the quality of drugs produced by Ranbaxy Laboratories and to check if the firm is following standard manufacturing norms at its various manufacturing plants.
In May this year, Ranbaxy had pleaded guilty to "felony charges" in the US Court of Maryland for manufacture and distribution of certain drugs not in conformity with the GMP regulation, which are considered as adulterated drugs as per the US law, and as a result agreed to pay a fine of $500 million.
The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India.
"The DCGI has already been ordered to review the good manufacturing practices compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities," Minister of State of Chemicals and Fertilisers Srikant Kumar Jena said in a written reply in Rajya Sabha.
To a query whether the company is selling "some of the medicines" in the country for which it was penalised in the US, Jena said as per the US law, any drug is considered adulterated if it is not manufactured, processed, packed in conformity with the current good manufacturing practice (GMP) regulations of the US Food and Drug Administration (USFDA).
"However, as per Drugs and Cosmetic Act and Rules, in India, manufacturing of drugs not in conformity of with GMP is viewed non compliance to GMP," Jena said.
Curtsy: Business Today Dated: August 23, 2013
1. M/s Ranbaxy Laboratories Ltd.,
2. M/s Wockhardt Ltd.,
3. M/s Hospira Healthcare India Pvt. Ltd.,
4. M/s RPG Life Sciences Ltd.,
The Drugs Controller General (India) [DCG(I)] has taken appropriate measures to ensure that the said firms manufacture drugs in compliance with the standards and Good Manufacturing Practices prescribed for them under the Drugs and Cosmetics Rules, 1945 through the system of inspections and testing of drugs.
This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the LokSabha today
DCGI asked to check quality of drugs sold by Ranbaxy: Govt
The government has ordered the Drug Controller General of India (DCGI) to check the quality of drugs produced by Ranbaxy Laboratories and to check if the firm is following standard manufacturing norms at its various manufacturing plants.
In May this year, Ranbaxy had pleaded guilty to "felony charges" in the US Court of Maryland for manufacture and distribution of certain drugs not in conformity with the GMP regulation, which are considered as adulterated drugs as per the US law, and as a result agreed to pay a fine of $500 million.
The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India.
"The DCGI has already been ordered to review the good manufacturing practices compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities," Minister of State of Chemicals and Fertilisers Srikant Kumar Jena said in a written reply in Rajya Sabha.
To a query whether the company is selling "some of the medicines" in the country for which it was penalised in the US, Jena said as per the US law, any drug is considered adulterated if it is not manufactured, processed, packed in conformity with the current good manufacturing practice (GMP) regulations of the US Food and Drug Administration (USFDA).
"However, as per Drugs and Cosmetic Act and Rules, in India, manufacturing of drugs not in conformity of with GMP is viewed non compliance to GMP," Jena said.
Curtsy: Business Today Dated: August 23, 2013
