Categories: Regulatory Norms

DCGI has asked Indian drug maker, Sun Pharmaceuticals to halt their activities related to clinical research at the company’s analytical laboratory in Mumbai.


Mumbai November 18, 2013:
Indian health regulator, the Drug Controller General of India, has asked Indian drug maker, Sun Pharmaceuticals to halt their activities related to clinical research at the company’s analytical laboratory in Mumbai.

It was observed that the drug firm had not satisfactorily obtained from the central government the required approvals for the laboratory operations. As decided by the drug regulator, no further drug applications would be accepted from the company. Also, the drug applications that the company had already filed from the Mumbai laboratory in discussion would not be processed until the company obtains requisite approvals for the lab.

The company confirmed of having received a letter from DCGI regarding this matter. The company assured that the necessary steps are being taken and they remain confident that the issue will soon be resolved. The company believes that they have complied with the necessary regulatory requirements and it is possibly due to the ambiguity in guidelines that has caused this issue. IGMPI. CCI Newswire

The Pharma Times News Bureau

Recent Posts

Lung Cancer Awareness Month

By Dr. C N Patil, HOD and Lead Consultant - Medical Oncology & Haemato-Oncology, Aster…

14 hours ago

Unmasking COPD: The Silent Respiratory Threat of Smoking

By  Dr. Pavan Yadav, Lead Consultant - Interventional Pulmonology & Lung Transplantation, Aster RV Hospital …

14 hours ago

Khazi India Foundation to Host Expert Cardiac Consultations in Adoni

Kurnool, November 20, 2024: Adoni, Andhra Pradesh, – The Khazi India Foundation is pleased to…

1 day ago

Aakash Healthcare Celebrates Children’s Day with Kids from Choti Si Khushi

New Delhi, November 20, 2024: Aakash Healthcare marked this year’s Children’s Day with a joyful…

1 day ago

Annual eye screening crucial for diabetic patients to protect eyesight: Dr Agarwals Eye Hospital

Dr Agarwals Eye Hospital, Bengaluru, is providing free consultations for diabetic patients aged 50 and…

4 days ago

7 Signs You Are Suffering From Protein Deficiency

By Ms. Archana S, Senior Nutritionist, Aster Whitefield Hospital, Bengaluru As an essential nutrient, protein…

4 days ago