To, June 15, 2015

Central Public Information Officer,

Central Drugs Standard Control Organization,
Directorate General of Health Services,
Ministry of Health and Family Welfare,
Government of India,
FDA Bhavan, ITO, Kotla Road,
New Delhi -110002

Dear Sir,

SUB: Application under RTI Act pertaining to drug safety alerts & recalls

You are requested to please consider this as an application under the Right to Information Act, 2005 and respond appropriately to the following queries with photocopies of the relevant document.

(i) Please provide the applicant with a copy of the guidelines or rules laid down by the CDSCO in order to issue “Drug Alerts” or “Recalls”.

(ii) Please provide the applicant with details of the action taken with regard to the ‘Drug Alerts’ issued by the CDSCO in April, 2014 i.e. does the CDSCO also prosecute the manufacturer? (Printout from CDSCO website enclosed herewith as Annexure A).

Further as provided under Section 6 (3) of the Right to Information Act, in case this application does not fall under your authority, I request you to transfer the same in the designated time (5 days) to the concerned authority and inform me of the same immediately. To the best of my knowledge the information sought does not fall within the restrictions contained in Section 8 and 9 of the Act and it pertains to your office.

A fee of Rs. 10 (Rupees Ten Only) has been deposited in the name of the Pay and Accounts Officer, DGHS, NirmanBhawan, New Delhi via the attached Postal Order, towards covering the charges for the RTI Application.

Warm Regards,

Prashant Reddy T.,Advocate,

C/o Lex One Partners, E-19, LGF,

Jungpura Extension,

New Delhi 110014

Email:

ANNEXURE A

Drug Alert for the Month of April 2014

Sl.
No. / Name of the drug/medical device/cosmetic / B. No, D/M, D/E,
Name of the Mfg. & Address / Reasons for Failure with report in Form-13/34 No. & Date / Drawn by / From
1. / Chlorpheniramine Tablets IP / B. No.: AT12082
Mfgdt: 07/2013
Expdt: 06/2015
Mfd by: M/s. Arbro Pharmaceuticals Ltd., 6/14, Kirti Nagar Industrial Area, New Delhi 110015. / Related Substances
32-8/2013-SS/
DCA(E)-140/126
Dt. 28.04.2014 / CDSCO, East Zone, Kolkata / CDL, Kolkata
2. / Pantal-40 Tablets (Pantoprazole Sodium Tablets), / B. No.: PFT 352
Mfgdt: 10/2013
Expdt: 09/2015
Mfd by: M/s. Caplet India Pvt. Ltd., 284/1, Bangur Avenue, Block-B, Kolkata 55 / Dissolution
32-8/2014-SS/
DCA(E)-301/75
Dt. 16.04.2014 / CDSCO, East Zone, Kolkata / CDL, Kolkata
3. / Chloroquine Phosphate Tablets IP / B. No.: BYM9070 R
Mfgdt: 11/2009
Expdt: 10/2014
Mfd by: M/s. Rajasthan Drugs & Pharmaceuticals Ltd., Road No. 12, VKI Area, Jaipur 302013 / Dissolution
32-8/2013-SS/
DCA(E)-104/65
Dt. 11.04.2014 / CDSCO, East Zone, Kolkata / CDL, Kolkata
4. / Chloroquine Phosphate Tablets IP / B. No.: BYM9069 R
Mfgdt: 11/2009
Expdt: 10/2014
Mfd by: M/s. Rajasthan Drugs & Pharmaceuticals Ltd., Road No. 12, VKI Area, Jaipur 302013 / Dissolution
32-8/2013-SS/
DCA(E)-189/64
Dt. 11.04.2014 / CDSCO, East Zone, Kolkata / CDL, Kolkata
5. / Reduced Osmolarity Oral Rehydration Salts IP / B. No.: 12208
Mfgdt: 11/2012
Expdt: 18 months from the date of mfg
Mfd by: M/s. Syndicate Pharma, 188, Sector F, Sanwer Road, Indore – 452015. / Seal Test, Description
32-9/2013-SS/
DCA(W)-349/72
Dt. 11.04.2014 / CDSCO, West Zone, Mumbai / CDL, Kolkata
6. / Reduced Osmolarity Oral Rehydration Salts IP / B. No.: 12209
Mfgdt: 11/2012
Expdt: 18 months from the date of mfg
Mfd by: M/s. Syndicate Pharma, 188, Sector F, Sanwer Road, Indore – 452015. / Seal Test, Description
32-9/2013-SS/
DCA(W)-348/71
Dt. 11.04.2014 / CDSCO, West Zone, Mumbai / CDL, Kolkata
7. / Trivastal L.A. (Piribedil Sustained Release Tablets) / B. No.: 121106
Mfgdt: 06/2011
Expdt: 05/2014
Mfd by: M/s. Serdia Pharmaceuticals (I) Pvt. Ltd., H-19, MIDC, Waluj, Aurangabad 431133 / Dissolution
32-9/2014-SS/
DCA(W)-214/7
Dt. 04.04.2014 / CDSCO, Goa / CDL, Kolkata
8. / Sterile water for Injection IP / B. No.: 2F541006
Mfgdt: 03/2011
Expdt: 02/2015
Mfd by: M/s. Marck Biosciences Ltd., Plot No. 876, N.H. No. 8, Hariyala, Tal. Matar, Dist. Kheda 387411, Gujrat. / Sterility
32-9/2013-SS/
DCA(W)-139/6
Dt. 04.04.2014 / CDSCO, West Zone, Mumbai / CDL, Kolkata
9. / Diclofenac Sodium Tablets / B No. 08/23-BG151
DM: 12/2013
DE: 11/2016
Mfg By: Biogenetic Drugs Pvt Ltd,
Jharmajri, Baddi-174103, HP / Disintegration Test / CDSCO, South Zone, Chennai / CDTL, Chennai
10. / Kamasutra Dotted Condoms (Desire Series) / B No. 1305060423
DM: 05/2013
DE: 04/2016
Mfg By: J K Ansell Ltd, Waluj, Aurangabad / Burst Volume & Burst Pressure / O/o Asst. Drugs Controller,
Thiruvananthapuram, Kerala / CDTL, Chennai
11. / Monamox Dry Syrup (Amoxycillin for Oral Suspension IP) / B No. DS-4660
DM: 11/2013
DE: 04/2015
Mfg By: Zee Laboratories, 47, Industrial Area, Paonta Sahib-173025 / Assay / CDSCO, South Zone, Chennai / CDTL, Chennai
12. / Herbage Herbal Overnight Cream / B No. SL-23
DM: 12/2013
DE: Best Before 3 years From mfg date
Mfg By: Herbage Personal Care Inc.,
2976, Palasuni, NH-5,
Bhubaneshwar. / Total Fatty Matter / Drugs Controller Department,
Bhubaneshwar,
Odisha / CDTL, Chennai
13. / V-GEL TABLETS / B. No. VG-2012,
D/Mfg. Oct, 2012 ,
D/Exp. Sep, 2014,
Mfg. By. M/s Vardhaman Pharma,
32, Industrial Area, Trilokpur Road, Kala Amb, Sirmpur. / Description, Uniformity of Wt., Assay
Report No. 09075/2014-15
Dated
02-04-2014 / Drugs Control
Department, Tripura / RDTL, Guwahati
14. / PENTADEL-40 TABLETS / B. No. N1210103,
D/Mfg. Oct, 2012,
D/Exp. Sep, 2014,
Mfg. By. M/s Talent Healthcare,
66-67, Sector-A, SIDCUL, IIE,
Haridwar, Uttrakhand-249409 / Dissolution
Report No. 09081/2014-15
Dated
08-04-2014 / Drugs Control
Department, Assam / RDTL, Guwahati
15. / MATIPHYLLINE TABLETS / B. No. MTT01-34,
D/Mfg. Jul, 2013,
D/Exp. Jun, 2015,
Mfg. By.M/s Unicure(India) Pvt. Ltd.,
C-22, Sector-3, Noida-201301 / Assay
Report No. 09107/2014-15
Dated
23-04-2014 / Drugs Control
Department, Assam / RDTL, Guwahati
16. / PARACETAMOL TABLETS / B. No. P-7667,
D/Mfg. Jul, 2011,
D/Exp. Jun, 2014,
Mfg. By. M/s Kamakhaya Laboratories,
21, Bonda Industrial Complex, Guwahati-781026 / Dissolution
Report No. 09126/2014-15
Dated
28-04-2014 / Drugs Control
Department,
Assam / RDTL, Guwahati
17. / ABSORBENT GAUZE / B. No. 22,
D/Mfg. Feb, 2012,
D/Exp. Jan, 2014,
Mfg. By. M/s Sri Kannan Surgical,
1-375, Sankaralinga, Moopanar Street, Samusigapuram-626102. / Misbranded
Report No. 09147/2014-15
Dated
29-04-2014 / Drugs Control
Department,
Arunachal Pradesh / RDTL, Guwahati