Date: 2014-05-26Category: Not ApplicableState: Union GovernmentCountry: India
Third Meeting of the Expert Committee on 04.06.2014 to examine the matters related to approval of the safety and efficacy of FDC permitted for manufacture for sale in the country without due approval from office of DCG(I)
**Executive Summary:**
This document announces the third meeting of the Expert Committee on June 4, 2014, to examine matters related to the approval of the safety and efficacy of Fixed Dose Combinations (FDCs) permitted for manufacture and sale in the country without due approval from the Office of the Drugs Controller General (DCG). The committee will review proposals from various pharmaceutical firms. Firms are requested to depute technical teams for presentations and submit presentation copies three days before the meeting.
**Key Points / Main Content:**
* **Meeting Details:**
* Date: June 4, 2014
* Time: 11:00 AM to 6:00 PM
* Location: Conference Room, 1st Floor, FDA Bhawan, Kotla Road, New Delhi.
* **Purpose of Meeting:**
* To seek expert opinion on proposals for approval of specific Fixed Dose Combinations (FDCs) based on data submitted by firms.
* **FDC Proposals for Review:**
* The meeting will review FDC proposals from various firms, including BRD Medilabs, L.Life Care Formulations, Macsur Pharma India Pvt Ltd, Synokem Pharmaceutical Ltd, Akums Drugs Pharmaceuticals Ltd, Talent Healthcare, Embiotic Laboratories, Acme Formulations, Wockhardt Ltd, Aeon Formulations, Orbit Lifesciences, Psychotropics India Limited, Vivimed Labs Ltd, and Windlas Biotech. Specific drug combinations and formulations are listed in the document.
* **Travel and Expenses:**
* TA/DA and honorarium will be paid as per Directorate's Office Memorandum No. 4012013DC Misc13PSC dated 03.02.2014.
* Air travel should be via Indian Airlines, and tickets purchased through Balmaer Laurie Co.
* **Instructions for Firms:**
* Firms must depute their technical team for presentation.
* Submit a copy of the presentation three days before the meeting.
* Bring drug samples in original packaging and package inserts.
* Manufacturers who have applied for above FDCs may also present their case before the committee
**Impact Analysis:**
* **Pharmaceutical Firms:**
* *Impact:* Their FDC proposals will be reviewed for approval, affecting their ability to manufacture and sell these combinations.
* *Action Required:* Depute technical teams for presentation, submit presentation copies three days before the meeting, bring drug samples and package inserts.
* **Expert Committee Members:**
* *Impact:* Responsible for evaluating the safety and efficacy data of FDCs and providing expert opinions on their approval.
* *Action Required:* Attend the meeting on June 4, 2014, and provide expert opinions on the proposals.
* **Drugs Controller General of India (DCGI):**
* *Impact:* Receives expert opinions from the committee to make informed decisions regarding the approval of FDCs.
* *Action Required:* Organize and facilitate the meeting, consider expert opinions, and communicate decisions to relevant stakeholders.
Key Entities Referenced
Directorate General of Health Services: An organization under which the Office of Drugs Controller General India operates.
Drugs Controller General India: The regulatory authority responsible for approving drugs and fixed dose combinations (FDCs) in India.
Fixed Dose Combinations (FDCs): A combination of two or more active pharmaceutical ingredients in a single dosage form.
FDA Bhawan, New Delhi: The location where the meeting of the Expert Committee will be held.
Expert Committee: A committee formed to examine matters related to the approval of the safety and efficacy of Fixed Dose Combinations (FDCs).
BRD Medilabs: One of the pharmaceutical firms whose Fixed Dose Combinations proposals are being reviewed.
Akums Drugs Pharmaceuticals Ltd.: One of the pharmaceutical firms whose Fixed Dose Combinations proposals are being reviewed.
Office Memorandum No. 4012013DC Misc13PSC dated 03.02.2014: A document providing the guidelines for TADA (Travel Allowance and Daily Allowance) and honorarium payments for attending the meeting.
F.No. 4-01/2013-DC (Misc. 13-PSC -Pt-Meeting)
Directorate General of Health Services
Office of Drugs Controller General (India)
(FDC Division)
FDA Bhawan,
, Kotla Road, New Delhi
Dated: 26 MAY 2014
To
1, Dr. Kamilakar Tripathi, Prof., Dept. of Medicine, Institute of Medical Sciences, BHU, Varanasi — 221
005
2. Dr. T.K. Dutta, Prof. & Head, Dept. of Medicine, JIPMER, Puducherry
3. Dr. B.Gupta, Prof. in General Medicine, North Delhi Medical College & Hindu Rao Hospital,
Malkaganj, New Delhi ~ 110 007.
4, Dr. Manjula Bhargava, Prof. & Head, Dept. of Pharmacology, SMS Medical College, Jaipur ~ 302 004
——-.... -5.—Dr,Sayed Moeid-Ahamed;—Associate Professor, Dept. of Anaesthesia and critical care, Alligarh
Muslim University, Aligarh, UP
6. Dr, Buddhadar Chowdhury, Addl. Professor, Dept. of Orthopaedic, IPNATC, AIIMS, Main Hospital,
Ansari Nagar, Infront of Safdarjung Hospital, New Delhi - 110 029
Subject:- Third Meeting of the Expert Committee on 04.06.2014 at 11:00 a.m. to 6:00 p.m. in the Conference
Room, 1* floor, FDA Bhawan, Kotla Road, Near National Bal Bhawan, New Delhi-110002, to
examine the matters related to approval of the safety and efficacy of Fixed Dose Combinations
(FDCs) permitted for manufacture for sale in the country without due approval from office of
DCG()) - regarding.
Sir,
Reference is invited to this Directorate's Office Memorandum No. 4-01/2013-DC (Misc13-PSC) dated
03.02.2014 on the subject cited above.
This office in the following proposals for approval of Fixed Dose Combinations seeks your expert
opinion of Expert Committee as to whether based on the data submitted by the firm, these proposals can be
approved,
S.No. | Name of firm/ Institute Drug
1 BRD Medilabs 3 tablets of Serratiopeptidase (enteric coated 20000 units) IP
10mg +Diclofenac Potassium BP 50mg & 2 tablets of
Doxycycline HCL IP 100mg Kit
2 ‘| L.Life Care Formulations L.Aceclofenac 100mg + paracetamol 325 mg + thiocolchicoside
. 4mg film coated tablet
2.aceclofenac 100 mg + paracetamol 325 mg + thiocolchiside 4
2.Macsur Pharma India Pvt Ltd | TMg/8 ing film coated tablet
3.Synokem Pharmaceutical Ltd 3.Aceclofenac 100mg +Paracetamol 325mg +Thiocolchicoside
dmg Film coated Tablet
4.Akums Drugs &
Pharmaceuticals Ltd 4.Aceclofenac 100mg/100mg +Paracetamol 325mg/325mg
+Thiocoichicoside 4mg/8mg Tablets
5.Talent Healthcare
; a
5.Aceclofenac 100mg +Paracetamol 325mg +Thiocolchicoside
8mg Film Coated Tablets6.Embiotic Laboratories 6.Aceclofenac 100mg +Paracetamol 500mg +Thiocolchicoside
4mg/8mg Film Coated Tablets
7.Acme Formulations
7.Aceclofenac 100mg +Parcetamol 325mg +Thiocolchicoside
4mg/8mg Tablets
3 Wockhardt Ltd aceciofenac IP 200 mg + rabeprazole sodium 20 mg Tablet
4 Akums Drugs Aceclofenac IP 100mg +Paracetamol IP 325mg +Rabeprazole
Pharmaceuticals Ltd Sodium IP 10mg Enteric Coated tablets :
3 Aeon Formulations Drotaverine HCI] IP 80mg + Clidinium Bromide USP 2.5mg +
Chlordiazepoxide IP Smg Film Coated Tablets
6 1.Talent Healthcare l.Lornoxicam IP 8mg +Paracetamol IP 325mg
+Serratiopeptidase [P 15mg Film Coated tablets
2.Lornoxicam 8mg +Paracetamol IP 325mg +Serratiopeptidase
2.Windlas Biotech IP 15mg Tablets
7 1 Talent Healthcare L.Lornoxicam IP 100mg +Paracetamol IP 325mg + Tramadol IP
37.5mg Film Coated tablets
2, Windlas biotech
2.Tramadol hydrochloride 37.5 mg + paracetamol 325 mg +
lornoxicam 8 mg film coated bilayered tablet
8 Orbit Lifesciences Lornoxicam 8mg +Paracetamol 325mg +Trypsin150000 AU
~ Tablets
9 Akums Drugs Paracetamol IP 300mg +Mefenamic Acid IP 150mg +Ranitidine
Pharmaceuticals HCL 100mg +Dicyclomine HCI IP {Omg Tablets ;
10 1.Vivimed labs 1.Tramadol HCl 37.5 mg + paracetamol 325 mg + dicyclomine
HCI £0 mg capsules
2.Tramadol HCI 37.5mg +Dicyclomine HC] 20mg +Paracetamol
2.Psychotropics India Ltd IP 500mg Uncoated Tablets
3. Wockhardt Ltd 3.Dicyclomine hydrochloride 10 mg/20 mg + tramadol
hydrochloride 50 mg/ 37.5 mg + Acetaminophen 325 mg capsule
1 Macsur Pharmaa Naproxen 300mg/550mg +Paracetamol IP 325mg Film Coated
Tablets
12 Acme Formulations Tapentadol 50mg +Paracetamol 325mg Tablets
A meeting has been convened on 04.06.2014 to evaluate the above proposals.
You are requested to kindly make it convenient to attend the said meeting on the said date.
TA/DA for attending the meeting as well as honorarium will be paid as per this Directorate’s Office
Memorandum No. 4-01/2013-DC (Misc13-PSC) dated 03.02.2014. If travelled by Air, it should be by Indian
Airlines only and the air tickets, if purchased through agent, should be purchased through M/s Balmaer
Laurie & Co, who are the authorized Govt. agent for this purpose.
You are requested kindly to make it convenient to attend the said meeting on 04.06.2014 at {1:00 a.m.
to 6:00 p.m. in the Conference Room, 1* floor,. FDA Bhawan, Kotla Road, Near National BalBhawan, New
Delhi-110002.
You are requested to confirm your participation by e-mail at fdedivision@gmail.com,
Yours faithfully,
: (Dr. GIN. Singh)
‘ - 0{¢Drugs Controller General (1): , Copy to: .
1. M/s. BRD MediLabs, Mr. Rahul Bansal, No. 23, DIC Industrial Area, Baddi, Himachal Pradesh - 173
205.
2. Lifecare Formulations Pvt. Ltd, Plot No. 2 & 3, 91/5, Link Road, Sonia Gandhi Nagar Extn. Near
Mettupalayam Industrial Estate, Mettupalayam, Puducherry — 605 009.
3. M/s. Synokem Pharmaceuticals Pvt. Ltd. Plot No. 35/36, Sector 6A, IIE, SIDCUL, Ranipur,
Haridwar-249403, Uttrakhand.
4. Macsur Pharmaa India Private Limited, 361, A, Vazhudavur Main Road, Mathirayar Palayam,
Pondicherry.
5. M/s. Talent healthcare, 66,67 sector 6A, SIDCUL, Haridwar, Uttarakhand-249403.
6. M/s. Akums Drugs & Pharmaceuticals Ltd., 19 to 21, Sector 6-A, ITE, Ranipur, Haridwar.
7. Mis, Embiotic Laboratories (P) Ltd. #20C, Ist Phase, Kumbalgodu Industrial Area, Mysore Road,
Kumbalgodu, Bangalore — 560 074.
8. M/s. Acme Formulations Pvt. Ltd., Ropar Raod, Nalagarh, Distt. Solan, H.P.-174101.
. M/s. Wockhardt Limited, Wockhardt Towers, BandraKurla Complex, Bandra (East), Mumbai-400051.
10. M/s, Windlas Healthcare (P) Ltd., Plot No. 183 & 192, Mohabewala Industrial Area, Dehradun:
248110, Uttarakhand.
11, M/s. Aeon Formulations Pvt, Ltd., R.S. No. 515/2 & 515/2 & 514, no. 152/7, Vinayagar Koil
Stret, Thirubuvanaipalayam, Mannadipet Commune, Puducherry-605107. ; :
a 12. M/s. Orbit Lifescience Pvt. Ltd. 13, kailash Darshan, 4th Floor, Nana Chowk, Mumbai — 400007.
13. M/s. Psychotropics India Limited, A-32, Sector -11, Opposite G. E, Motors, Faridabad, Haryana — ve
121007.
14, M/s. Vivimed Labs Ltd., D-9, Industrial Area, Haridwar, Uttarakhand.
Note for Firms:
- You are requested to depute your technical team for presentation. As application for same FDC have been
received from multiple applicants, you are requested to be present at CDSCO on 04.06.2014 at 11:00 a.m.
_ to 6:00 p.m, in the Conference Room, 1* floor, FDA Bhawan, Kotla Road, Near National Bal- Bhawan,
New Delhi - 110 002 to make presentation as considered necessary by the committee.
_- Also requested to submit the copy of the presentation of the respective proposals before 3 days of the
meeting date.
- Also requested to bring Drug Samples in original pack as well as package insert while coming for
presentation.
- Any other manufacturer who have applied above FDC’s may also present their case before the
committee,
Yours faithfully,
; (Dr. G.N, Singh)
* Drugs Controller/General (1)