**Executive Summary:**
The Drugs Controller General of India has scheduled a meeting of the Expert Committee on June 11, 2014, to examine matters related to the approval of the safety and efficacy of Fixed Dose Combinations (FDCs) already permitted for manufacture and sale in the country without due approval. The committee will evaluate proposals for approval based on data submitted by various firms. Firms are requested to send a technical team for presentations, submit presentations in advance, and bring drug samples to the meeting.
**Key Points / Main Content:**
* **Meeting Details:**
* Date: June 11, 2014
* Time: 11:00 a.m. to 6:00 p.m.
* Location: Conference Room, 1st floor, FDA Bhawan, Kotla Road, New Delhi.
* **Purpose of Meeting:**
* To examine matters related to the approval of the safety and efficacy of Fixed Dose Combinations (FDCs).
* To evaluate proposals for FDC approval based on submitted data.
* **FDC Proposals for Evaluation:**
* The Expert Committee will review proposals from various firms.
* Multiple applications for the same FDCs have been received.
* FDCs containing Azithromycin, Cefixime, Cefpodoxime, Levofloxacin, Beclomthasone Dipropionate, Clotrimazole, Chloramphenicol, Gentamycin Sulphate, Lignocaine HCI, Ciprofloxacin HCI, Phenazopyridine HCI, Roxithromycin, Serratiopeptidase, Sulphadiazine sodium and Trimethiprim
* **Requirements for Firms:**
* Depute a technical team for presentation.
* Submit a copy of the presentation at least 3 days before the meeting.
* Bring drug samples in original packaging and package insert.
* Confirm participation by email at fdcdivision@gmail.com.
* **Financials:**
* TADA (Travel Allowance and Daily Allowance) and honorarium will be paid as per Ministry of Health & Family Welfare order No. X.19029/52011-DFQC dated 31.3.2011.
* Air travel should be by Indian Airlines, and tickets purchased through Balmer Laurie & Co.
**Impact Analysis**
* **Expert Committee Members:**
* *Impact:* Required to attend the meeting and provide expert opinions on the safety and efficacy of FDCs.
* *Action Required:* Attend the meeting on June 11, 2014, and review the provided documentation to offer informed opinions. Confirm participation by email.
* **Pharmaceutical Firms (e.g., Hetero Labs, East West Pharma, Akums Drugs Pharmaceuticals Ltd., etc.):**
* *Impact:* Opportunity to present data supporting the approval of their FDC proposals.
* *Action Required:* Depute a technical team for presentation, submit a copy of the presentation at least 3 days before the meeting date, bring drug samples in original packaging and package insert, and attend the meeting on June 11, 2014.
* **Drugs Controller General of India (DCGI):**
* *Impact:* Responsible for organizing and overseeing the expert committee meeting and making decisions based on the committee's recommendations.
* *Action Required:* Ensure the meeting is conducted smoothly, provide all necessary documentation to the committee, and communicate decisions to the relevant stakeholders.
Key Entities Referenced
Drugs Controller General India: Office responsible for drug regulation mentioned in the document header.
FDA Bhawan, Kotla Road, New Delhi: Location of the Drugs Controller General India office and the venue for the expert committee meeting.
Expert Committee: Committee formed to examine matters related to approval of the safety and efficacy of Fixed Dose Combinations.
Fixed Dose Combinations (FDCs): Pharmaceutical products containing a combination of two or more active drugs in a single dosage form, the focus of the expert committee's review.
Hetero Labs Ltd., Hyderabad, Andhra Pradesh: Pharmaceutical company that has submitted proposals for approval of Fixed Dose Combinations.
TN Medical College BLY Nair Charitable Hospital, Mumbai, Maharashtra: Medical college and hospital where Dr. Renuka Kulkarni Munshi works.
Ministry of Health & Family Welfare: The government ministry under which TADA and honorarium will be paid.
UCMS, New Delhi: University College of Medical Sciences (UCMS) in New Delhi, India. Affiliation of Dr. Iqbal Kaur and Dr. Subhash Giri.
F.No. 4-01/2013-DC (Mise. 13-PSC -Pt-Meeting)
Directorate General of Health Services
. Office of Drugs Controller General (India} ,
(FDC Division)
FDA Bhawan,
* Kotla Road, New Delhi
Pact 26 MAY 2014
To
Dr. Renuka Kulkarni Munshi, Associate Prof. & Incharge, Clinical Pharmacology, TN Medical College
& BLY Nair Charitable Hospital, Mumbai
YFYD Dr. Iqbal Kaur, Prof: & Head, dept. of Microbiology, UCMS, New Delhi ~ OO
Dr. Subhash Giri, Dept. of Medicine, UCMS, New Delhi
Dr. Niranjan Mohanty, Prof. & Head, Dept. of Paediatrics, SCB Medical College, Cuttack-753014.
Dr. B.Gupta, Prof. in General Medicine, North Delhi Medical College & Hindu Rao Hospital,
Malkaganj, New Delhi — 110 007.
Subject:- Fourth Meeting of the Expert Committee on 11.06.2014 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,
Sir,
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.
Reference is invited to this Directorates 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.
Age | Name of firm/ Institute Drug
nda
no.
1 1.Hetero Labs 1. Azithromycin 125mg/250mg/500mg + Cefixime
100mg/200mg/200mg Tablets
2. Valence Healthcare
2.Cefixime (As Trihydrate) 200mg +Azithromycin Drihydrate IP
3. Relax Pharmaceuticals 250mg Film Coated Tablets .
4, East West Pharma 3, Cefixime 200/200mg + azithromycin 250/500mg Tablet
5. FDC Ltd 4. Cefixime Trihydrate IP 200mg +Azithomycin Dihydrate IP 500mg
Fiim Coated tablets
6. Akums Drugs & . . —
Pharmaceuticals [td 5. Cefixime 100mg +Azithromycin 125mg Dispersible tablets
6-Azithromycin 250mg/500mg +Cefixime 200mg/200mg Tablets -
2 MDC Pharmaceuticals Cefixime IP eq, to anhydrous Cefixime 200mg +Acetyl Cysteine USP
300mg Film Coated Tablets
3 Akums Drugs & | Cefixime IP eq. to anhydrous Cefixime 400mg +levofloxacin
Pharmaceuticals Hemihydrate IP eq, to Levofloxacin 500mg Tablets4 1.Talent Healthcare 1, Cefpodoxime Proetile IP 200mg +Azithromycin Dihydrate IP
250mg Film Coated tablets
2. Cefpodoxime Proxetil 200mg +Azithromycin 250mg Film Coated
2.Macleods Pharmaceuticals | Tablets
3.Aeon Formulations 3. Cefpodoxime 320mg +Azithromycin 500mg Tablets
4.Aeon Formulations 4. Cefpodoxine 100mg +Azithromycin 125mg Dispersible tablet
§.Orbit Lifesciences 5. Azithromycin Dihydrate IP eq. to Azithromycin 250mg/500mg
+Cefpodoxime Proxetil IP eq. to Cefpodoxime 200mg Film Coated
tablets
5 Orbit. Life Science cefpodexime-proxetil 200 mg + dicloxacillin sodium 500 mg tablets]
6 Relax pharmaceuticals Pvt. | Cefpodoxine proxetil 200 mg + levofloxacin hemihydrate 250° mg
Ltd tablets
7 LAkums Drugs & | L.Levofloxacin 250mg/500mg +-Azithromycin 250mg/500mg Tablets
Pharmaceuticals
2.Anhydrous Azithromycin 250m¢/S00mg +
2.Gelnova laboratories Anhydrous Levofloxacin 250mg/500mg Tablets
3.Synokem pharma 3.Azithromycin 250 mg/500 mg + Levofloxacin 250 mg/500 mg film
coated tablet
4.Hetero Labs
4.Azithromycin 250mg/500mg +Levofloxacin 250mg/500mg Tablets
8 Arion Healthcare Beclomthasone Dipropionate 0.025%w/v + Clotrimazole [%w/v +
Chloramphenicol S5%w/vy +Gentamycin Sulpahte 0.3%w/v +
Lignocaine HCI 2%w/v Ear Drops
9 Aeon Formulations Ciprofloxacin HCI IP 250mg +Phenazopyridine HCI USP 200mg Film |
; Coated Tablets
10 Alembic Pharmaceuticals Roxithromycin IP 150mg +Serratiopeptidase 10mg Film Coated
Tablets
1 1.Akums drugs & | 1.Sulphadiazine sodium 100 mg + trimethiprim 20 mg oral powder
pharmaceuticals limited :
2.Trimethoprim IP 200mg +Sulphadiazine IP 1000mg Uncoated
2.Bushal Healthcare Tablets
A meeting has been convened on 11.06.2614 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 Ministry of health & Family Welfare
order No. X.19029/5/2011-DFQC dated 31.3.2011. 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 11.06.2014 at 11:00 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 fdcdivision@gmail.com.
Yours fajthfully,
(Dr. G.N./Singh)
Drugs Controller Genpral (1)Copy to:
1. M/s. Hetero Labs Ltd., Hetero Corporate, Industrial Estates, H. No. 7-2-A2, Sanathnagar, Hyderabad-
500018, Andhra Pradesh.
2. Mis, East West Pharma, No, 10, 2nd Cross,
Maravaneri, Salem — 636007, Tamil Nadu.
raw M/s, Akums Drugs & Pharmaceuticals Ltd., 19 to 21, Sector 6-A, HE, Ranipur, Haridwar.
M/s. MDC Pharmacueticals Pvt. Limited, Plot No. 213, Industrial Area, Phase I, Chandigarh-160002.
M/s, FDC Limited, 142-48, S.V. Road, Jogeshwari (WW), Mumbai-400102.
M/s. Talent healthcare, 66,67 sector 6A, SIDCUL, Haridwar, Uttarakhand-249403. .
M/s, Relax Pharmaceuticals, 48-B, Industrial Area, Comdpur
Paonta Sahib, Himachal Pradesh.
8. M/s. Valence Healthcare, Plot No. 8 & 9, New Industrial Area, Village Bai Attarian, P.O, Kandrori, (Near. __ __
Pathankot) Tehsil: Indrora, Dist. Kangra, Himachal Pradesh a
9 M/s. Macleods Pharmaceuticals Ltd., Atlanta Areade, 3 rd Floor, Church Road, Near Leela Hotel,
Andheri-Kurla Road, Andheri (E), Mumbai-400059.
10. 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.
1i. M/s. Orbit Lifescience Pvt. Ltd. 13, kailash Darshan, 4th Floor, Nana Chowk, Mumbai — 400007.
12, M/s. Synokem Pharmaceuticals Pvt. Ltd. Plot No. 35/36, Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-
249403, Uttrakhand. .
13. Gelnova Laboratories (I) Pvt. Ltd., C-125 TTC Industrial Area,, Mahape (Pawane), Pawane Midc Road
Number 7, Electornic Zone, Mahape, Navi Mumbai, Maharashtra 400705.
14. M/s. Arion Healthcare Private Limited, Mr. Abhay Jain, SCO 907, 2nd Floor, N.A.C., Manimajra,
Chandigarh - 160017, Chandigarh.
is, M/s. Alembic Pharmaceuticals Ltd., Alembic Road, Vadodara-390003, Gujarat.
16. MIs. Relax Photnacertreodls Put. Urol, (Unit!) 49-A-B, GonolpurtnolaeTrsa) Area
Note for Firms: Paonts Sahih, Distee Siepneuty Cit i?) ~1780 1S.
sw
- 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 11.06.2014 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 coe
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)