**Summary:**
This order, issued by the Drugs Controller General of India (DCGI), Dr. G. N. Singh, on February 13, 2014, addresses the application of Ms. Arion Healthcare, located in Village Kishanpura, Baddi, Nalagarh Highway, Baddi, Distt. Solan, Himachal Pradesh, for permission to manufacture and market a Fixed Dose Combination (FDC).
Based on a joint inspection conducted on December 17, 2013, and subsequent examination of submitted documents, the DCGI has determined that the data provided by Ms. Arion Healthcare was fabricated and forged. This determination was supported by the inspection report, submitted documents, and the admission of Mr. Ravi Jain, Partner at Arion Healthcare. Mr. Ashok Khurana, Private Consultant, and Mr. Manoj, QA Manager, Delhi, were identified as having fabricated the documents with the permission and consent of the company.
Consequently, the application submitted by Ms. Arion Healthcare to the FDC Division is rejected. Furthermore, Ms. Arion Healthcare is debarred from applying to any office of the Central Drugs Standard Control Organisation (CDSCO) for any purpose for a period of 5 years, effective from the date of this order.
Copies of this order have been sent to all Zonal/Sub-Zonal Offices of CDSCO and to the State Drugs Controlling Authority, Nagar Panchayat Bhawan, Sai Road, Baddi, Distt. Solan, Himachal Pradesh, with a request to cancel the product permissions issued to the firm in respect of the products listed in Annexure A. File No. 41732006DC Pt. refers to this case within the Directorate General of Health Services.
Key Entities Referenced
Directorate General of Health Services: An organization, likely part of the Indian government's health administration.
Drugs Controller General India: The regulatory authority in India responsible for drug control.
FDC Division: A division within the Drugs Controller General India, likely focused on Fixed Dose Combinations.
Mr. Ravi Jain, Partner: An individual who was a partner at the inspected firm.
Mr. Ashok Khurana, Private Consultant: An individual identified as a private consultant who allegedly fabricated documents.
Mr. Manoj, QA Manager, Delhi: An individual identified as QA Manager in Delhi who allegedly fabricated documents.
Fixed Dose Combination FDC: A type of pharmaceutical product that combines two or more active ingredients in a single dosage form.
Ms. Arion Healthcare, VillageKishanpura, Baddi, Nalagarh Highway, Baddi, Dsit. Solan, Himachal Pradesh: The name and address of the firm subject to the order. Located in Himachal Pradesh, India.
> +
File No. 4-173/2006-DC (Pt. Arion)
Directorate General of Health Services
Office of Drugs Controller General (India)
(FDC Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: | b|2] | 4
ORDER
of Cef- ixY io mu e +fi l Oe fd l oa xn a a cp ip nl i tc aa blt ei to sn . in this Directorate for obtaining permission to manufacture and marketed FDC
After examining the documents submitted by you, it appeared that data submitted by you may not be
authentic. Accordingly, a joint inspection was conducted at your premises on 17.12.2013 to verify the
authenticity of the data submitted by you. The inspecting team submitted its report and they opined that
documents submitted by you are fictitious and forged. The same was also confirmed by Mr. Ravi Jain, Partner
at the time of inspection.
After examining the inspection report and documents submitted by you as well by admission of Mr. Ravi
Jain, Partner, it was observed that Mr. Ashok Khurana, Private Consultant as well as Mr. Manoj, QA Manager,
Delhi have fabricated all documents submitted to this office for obtaining permission to manufacture Fixed
Dose Combination (FDC) with the permission and consent of you.
frt e oa pk ule nyn d ta cog oY a ntio vhn iiu s s n t cv o iy fi no fd giue /c s ef at oh toi r ins ss fuo 0 abf 5 cf m t.i i o0c t r3e t y. .il 2ne 0gt 1t f 4er o . r Td g ha e et d e rd d e: o p c l1 yu3 m. se0 un2 bt. ms2 i0 tf1 to4 er d ow b be t yr a e i y n oa i us n k g we a ad p spt ro e o xe v ax a mp l il fa ni r en o d m a bs t y h it tso h o iw f sf h i Dy c ie r . ea cc Y tt o oi ro u an ts es u h b ao m nu i dl t d t w e an do s yt o nb u oe tr
!
in conniIn v av ni ce ew wo if t f ha c yts o ua rn d c oc ni sr uc lu tm as nt ta nc ae ns d, Qit Ais a Mm ap nl ae g ec rl .ea r T t hh ea rt e fy oo ru e ,h a yv oe u rs ub alm li t at pe pd l if co ar tg ie od n sa n pd e nf dab ir ni gc a it ne d Fd Dat Ca
Division are hereby rejected and you are also debarred for applying to any of the offices of CDSCO for any
purpose for a period of 5 years.
_ Youyg Faithfully,
(Dr. G. N. Singh)
Drugs Controller Géneral (India)
To,
M/s. Arion Healthcare,
Village-Kishanpura, Baddi, Nalagarh Highway,
Baddi, Dsit. Solan, Himachal Pradesh.
Copy for necessary action to:-
1. All Zonal/Sub Zonal/Offices of CDSCO.
2. State Drugs Controlling Authority, Nagar Panchayat Bhawan, Sai Road, Baddi , Distt. Solan,
Himachal Pradesh-with the request to cancel the product permissions issued to firm in respect of
aforesaid products as per Annexure A.