Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Downloads/Documents & Publications

S.No.
 Title Downlaod (pdf) File Size
1 Guidance document for Veterinary Biologicals 2478 KB
2 Annual performance Appraisal Reports (ACR group C)(Related to Employees) 3,030kb
3 Travelling allowance bill for tour(Related to Employees) 334kb
4 Application for leave or for extension of leave(Related to Employees) 979kb
5 Leave Travel Concession Bill(Related to Employees) 1,631kb
6 TRAVELLING ALLOWANCE BILL FOR TRANSFER 622kb
7 Organ(s) and tissue(s) Donor Form 254kb
8 Advance LTC Form(Related to Employees) 334kb
9 Joining Report after EL 121kb
10 Assessment report Form 1,396kb
11 Nomination Form 2,723kb
12 Annual performance Appraisal Reports (ACR group A-B)(Related to Employees) 2,540kb
13 Medical reimbursement claim Form(Related to Employees) 484kb
14 Application for withdrawal from G.P.F Form(Related to Employees) 243kb
15 Adverse Drugs Reaction Reporting Form 712kb
16 Annexure Sheet for submit the Application Form(For Stakeholders) 64kb
17 Guidelines under new penal Provision 199kb
18 Challan (TR-6) for depositing fee(For Stakeholders) 10kb
19 Good Manufacturing Practices 282kb
20 Proforma for Drugs Controller Reporting activities 13kb
21 Right to Information Act, 2005 (RTI) - Application Form 56kb
22 Application for advance G.P.F Form(Related to Employees) 957kb
23 The Drugs & Cosmetics (Amendment) Act, 2008 and Guidelines 5,058kb
Date
 Documents Pdf
1 Pantoprazole Sodium IP Aspirin IP Capsules 664 KB
2 Acodiamide Hydrochloride 300 mg 1873 KB
3 Benidipine Hydrochloride + Chlorthalidone IP Film coated tablets (Phase III) 273 KB
4 Ulinastatin for Injection 1431 KB
5 NitazoxanideTablet 500 mgHydroxychloroquine Tablet 200 mg 1361 KB
6 Cocculus hirsutus 1154 KB
7 Favipiravir 12309 KB
8 NitazoxanideTabet 500 mg and Hydroxychloroquine Tablet 200 mg 1456 KB
9 Dustasteride Topical solution 0.01% w/v, 0.02% w/v and 0.005% w/v 679 KB
10 Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium +Cilnidipine IP Film coated tablets (Phase III) 309 KB
11 CA-170 234 KB
12 vaporized cannabinoids 225 KB
13 Oral Pharmacokinetics and Safety of TRC041266 Powder with TRC4186 Tablet 195 KB
14 Glycopyrrolate IP eq. to Glycopyrronium + Arformoterol Tartrate eq. to Arformoterol Inhalation solution (Phase III) 303 KB
15 Bilastine + Montelukast Sodium IP eq. to Montelukast Film coated tablets 288 KB
16 Canagliflozin + Metformin HCl Film coated tablets (Phase IV) 216 KB
17 Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Chlorthalidone IP Film coated tablets (Phase III) 336 KB
18 Inactivated Hepatitis A vaccine 281 KB
19 Selpercatinib 491 KB
20 zelnidipine 8 mg plus Telmisartan 40 mg and Azelnidipine 16 mg plus Telmisartan 40mg tab versus Azelnidipine tab 16 mg and Telmisartan tab 40 mg 376 KB
21 ZYBK2 206 KB
22 Estradiol Valerate 4mg SR Table 1773 KB
23 Pregabalin IP + Duloxetine Hydrochloride IP eq. to Duloxetine (as delayed release pellets) hard gelatin capsules (Phase III) 248 KB
24 Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Chlorthalidone IP Film coated tablets (Phase III) 318 KB
25 Evenamide (NW-3509)2 269 KB
26 Tirzepatide 256 KB
27 AR-301 251 KB
28 Evenamide2 379 KB
29 Bedaquiline, Delamanid 360 KB
30 Bedaquiline Tablets 100mg 255 KB
31 Tropifexor (LJN452) & licogliflozin 429 KB
32 Dienogest (Visanne®) 196 KB
33 Hydroxychloroquine Sulfate Tablet 200mg/300 mg 788 KB
34 Goserelin 10.8mg Injection1 1460 KB
35 Hydrocortisone Acetate Suppositories, 25 Mg 303 KB
36 Ipatasertib 505 KB
37 Inactivated Therapeutic Tuberculosis Vaccine 185 KB
38 Fingolimod capsule 2608 KB
39 Silodosin + Solifenacin Succinate Ph. Eur. Capsule (Phase III) 337 KB
40 Glimepiride IP + Voglibose IP + Metformin HCl IP (as ER) uncoated bilayered tablet (Phase IV) 242 KB
41 Remogliflozin Etabonate + Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin Film coated tablets (Phase III) 302 KB
42 Mirabegron + Solifenacin Succinate tablets (Phase III) 232 KB
43 Ivabradin Tablet 2543 KB
44 sacubitril/valsartan 251 KB
45 Goserelin 10.8mg Injection 381 KB
46 Bilastine + Montelukast Sodium IP eq. to Montelukast uncoated tablet (Phase III) 297 KB
47 Brimonidine Tartrate 0.1% Ophthalmic Solution 325 KB
48 Selonsertib 1460 KB
49 Evenamide(NW-3509/008/II/2019) 375 KB
50 PF-06741086 493 KB
51 Capmatinib 249 KB
52 Remogliflozin Etabonate Vildagliptin film coated tablet 1222 KB
53 Hydrocortisone Acetate 358 KB
54 Ripasudil HCl Hydrate eq. To Ripasudil Timolol Maleate IP Eq. To to Timolol eye drops 1008 KB
55 Cephalexin extended release Clavulanate Potassium tablet 1016 KB
56 Goserelin 3.6 mg Injection 495 KB
57 Ceftazidime 321 KB
58 Triamcinolone acetonide IP Lignocaine HCl IP Gel 712 KB
59 Ceftazidime-Avibactam 489 KB
60 GSK2831781 502 KB
61 Lipidol 3028 KB
62 Gepotidacin 256 KB
63 Evenamide(NW-3509/006/III/2019) 509 KB
64 Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze Dried) 193 KB
65 Evenamide(nw-3509) 509 KB
66 Prohance® (Gadoteridol 279.3 mg/mllnjection 2667 KB
67 Dalbavancin 2754 KB
68 Azelnidipine Olmesartan Medoxomil IP tablets 1260 KB
69 opivacaine Hydrochloride USP eq. to anhydrous Ropivacaine hydrochloride Dextrose IP per ml injection 959 KB
70 Benidipine HCl Chlorthalidone IPTelmisartan IP Film coated bilayered tablets 876 KB
71 Rosuvastatin IP Teneligliptin Film coated tablet 1099 KB
72 SB3 249 KB
73 International Centre for Genetic Engineering and Biotechnology CampusBivalent (JAIVAC-2: PfMSPFu24 +PfF2/ Alhydrogel) P. falciparum malaria vaccine 167 KB
74 Baricitinib eli lily 509 KB
75 TRUNCATE – TB (tuberculosis) 3884 KB
76 Lenvatinib Capsules 4 mg and 10 mg 330 KB
77 Azilsartan KamedoxomilChlorthalidone IP tablet 654 KB
78 Ticagrelor 120/180 mg SR Tablet 2652 KB
79 AUR101 3310 KB
80 Desidustat Tablet versus Epoetin alfa Injection 2558 KB
81 Diptheria,Tetanus, Pertussis (Whole cell),Hepatitis B, Poliomyelitis (inactivated) and Haemophilus Influenzae Type b conjugate Vaccine (Adsorbed) [DTwPHepB-IPV-Hib vaccine (Adsorbed 207 KB
82 AUR101 3310 KB
83 PNB-001 267 KB
84 Recombinant Hepatitis E Vaccine, Single Human Dose 266 KB
85 Zileuton Ointment 1.25% and 5.0% 702 KB
86 Inotuzumab 370 KB
87 Iodixanol 2023 KB
88 Avanafil tablets 100 mg & 200 mg 1223 KB
89 LNP023 366 KB
90 Concizumab Prophylaxis 508 KB
91 Concizumab 327 KB
92 Etrasimod( IQVIA RDS) 513 KB
93 Etrasimod( IQVIA) 502 KB
94 Brazikumab 491 KB
95 Etrasimod 485 KB
96 Inactivated Hepatitis A Vaccine (Adsorbed) I.P.6nov 262 KB
97 FEIBA 403 KB
98 CT-P13 471 KB
99 LNP023(Rituximab) 260 KB
100 Oral Baricitinib 503 KB
101 GSK3196165 284 KB
102 Ruxolitinib 310 KB
103 Ruxolitinib 310 KB
104 Spironolactone Topical Cream 5% 1495 KB
105 Apremilast Film Coated 10/10/30mg Tablets 2755 KB
106 Tenofovir Alafenamide, Emtricitabine and Bictegravir 2682 KB
107 Sofosbuvir 400 mg Tablet 2627 KB
108 Typhoid Vi conjugate VaccineRa 276 KB
109 Cilnidipine IP Azilsartan Kamedoxomil eq. to Azilsartan Medoxomil tablets 609 KB
110 Azelnidipine Telmisartan tablets 624 KB
111 Benidipine HCl IPTelmisartan IP Film coated tablets 641 KB
112 Typhoid Vi conjugate Vaccine30sep 185 KB
113 Methylcobalamin Nasal spray 500 mcg 284 KB
114 Certican / Zortress(everolimus EVR) 312 KB
115 Tirzepatide1 313 KB
116 Tirzepatide 313 KB
117 QL1205 Versus Lucentis 304 KB
118 Bupivacaine Hydrochloride IP eq. to anhydrous Bupivacaine Hydrochloride Fentanyl Citrate IP Eq. to Fentanyl injection 672 KB
119 AT-10 (2-oxoclopidogrel bisulfate 2845 KB
120 HP-hMG and Menopur® 2143 KB
121 Inactivated Hepatitis A vaccine (Adsorbed) I.P. 187 KB
122 Rabies Vaccine, Human, I.P. 187 KB
123 Brazikumab 393 KB
124 Meningococcal Conjugate Vaccine 510 KB
125 evenamide or placebo 273 KB
126 Ribociclib plus goserelin acetate 434 KB
127 semaglutide versus placebo 477 KB
128 Leuprolide acetate 2291 KB
129 MYL-1701P and Eylea 299 KB
130 Netarsudil Ophthalmic solution 0.02% 3055 KB
131 ligelizumab (QGE031) 328 KB
132 Montelukast sodium eq. to Montelukast IP + Bilastine film coated tablet (Phase III Clinical Trial) 710 KB
133 Montelukast sodium eq. to Montelukast IP + Bilastine film coated tablet (Phase III Clinical Trial) 710 KB
134 Montelukast sodium eq. to Montelukast IP + Bilastine film coated tablet (Phase III Clinical Trial) 710 KB
135 Efonidipine Hydrochloride Ethanolate + Telmisartan IP + Chlorthalidone IP Tablets (Phase III Clinical Trial 705 KB
136 Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Cilnidipine IP film coated tablet (Phase III Clinical Trial) 697 KB
137 Mirikizumab 625 KB
138 Azelnidipine IP + Chlorthalidone IP Uncoated Tablet (Phase III Clinical Trial) 617 KB
139 Tranexamic acid 1667 KB
140 Menopausal Gonadotropin 2618 KB
141 Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-Valent) 259 KB
142 baloxavir marboxil 492 KB
143 k0706 592 KB
144 traconazole 1373 KB
145 Semaglutide (SOUL) 2366 KB
146 Mirikizumab (UC) 625 KB
147 Semaglutide 2366 KB
148 Filgotinib (rheumatoid Arthritis) 519 KB
149 Filgotinib 591 KB
150 Fluticasone Propionate + Salmeterol inhalation Powder (Phase III Clinical Trial) 531 KB
151 Fluticasone Propionate + Salmeterol inhalation Powder (Phase III Clinical Trial) 531 KB
152 Tigilanol Tiglate 368 KB
153 Capivasertib + Paclitaxel versus placebo 228 KB
154 HD204 to Avastin® 513 KB
155 Baricitinib 500 KB
156 Baricitinib 500 KB
157 Oral Baricitinib 316 KB
158 Evenamide 608 KB
159 Beclomethasone 1765 KB
160 Aceclofenac Topical ointment 1.5% w/wIII 2285 KB
161 Evenamide 608 KB
162 Ulipristal acetate tablet 30mgIII 2555 KB
163 IVIEW-1201 264 KB
164 Sertaconazole Nitrate + Terbinafine HCl cream (Phase III Clinical Trial) 643 KB
165 INTP24 against Avastin® in 468 KB
166 Ribiciclib 289 KB
167 PMZ-1620 320 KB
168 PMZ-1620 320 KB
169 Adenosine IP + Minoxidil IP Topical solution (Phase II Clinical Trial) 626 KB
170 Benidipine Hydrochloride + Metoprolol Succinate eq. to Metoprolol tartrate IP Film coated tablet (Phase III Clinical Trial) 357 KB
171 Benidipine Hydrochloride JP + Chlorthalidone IP Film coated tablets (Phase III Clinical Trial 580 KB
172 AS012 230 KB
173 Lenalidomide 267 KB
174 Osimertinib in Combination with Savolitinib 492 KB
175 Crizanlizumab 303 KB
176 Biapenem 300 mg inj 368 KB
177 Saroglitazar tablet 4mg II 2058 KB
178 Sulbactam-ETX2514 427 KB
179 Rifapentine plus Isoniazid 259 KB
180 IQVIA 213 KB
181 Ropivacaine Readyfusor 2mg/mlIII 2629 KB
182 Acotiamide ER tablet 300 tabletIII 2090 KB
183 Recombinant Hepatitis E Vaccine 155 KB
184 Toujeo 300 Units/ml 486 KB
185 Oral Galactose 252 KB
186 Vi-capsular Polysaccharide-CRM197 Conjugate Typhoid Vaccine 284 KB
187 Guselkumab 566 KB
188 Semaglutide 429 KB
189 Semaglutide (NN9535-4352) 429 KB
190 Typhoid Vi Conjugate Vaccine 280 KB
191 Pneumococcal polysaccharide conjugate vaccine (14-valent) 283 KB
192 Curcumin (Biocurcumax cap) as an adjunct drug to standard therapy [(Artesunate) + (Sulfadoxine-Pyrimethamine) tablet] 238 KB
193 2Ó-Methyl-Phosphorothioate Anti Sense Oligoribonucleotide for treating patients with Duchenne Muscular Dystrophy 231 KB
194 Xlucane versus Lucentis® 443 KB
195 Neoadjuvant/adjuvantDurvalumab 427 KB
196 Durvalumab 427 KB
197 Rituximab Biosimilar (DRL_RI) with MabThera® 434 KB
198 METREXASSIST™ 194 KB
199 Baricitinib 194 KB
200 Tirzepatide 432 KB
201 Phenobarbital Sodium Injection 191 KB
202 FDC of Daclatasvir Dihydrochloride Eq. to Daclatasvir 60mg Sofosbuvir 400mg film coated tablets (Phase IV) 1031 KB
203 C.O.M.B.A.T 222 KB
204 Sodium Fusidate eq. To Fusidic acid 2% w/w (Sofinox gel) 3105 KB
205 esidustat vs Darbepoetin 295 KB
206 Saroglitazar 2mg & 4mg Tablet 2767 KB
207 Tacrolimus lipid tablet 3mg 2677 KB
208 TRC160334 295 KB
209 Olaparib 250 KB
210 Oral Nafithromycin vs oral Moxifloxacin 417 KB
211 Rivaroxaban tablets 2.5mg (Xarelto®) 2579 KB
212 Typhoid Conjugate vaccineApril11 301 KB
213 Fitusira 419 KB
214 SB12 and Soliris 202 KB
215 Galcanezumab 327 KB
216 Durvalumab 208 KB
217 SAR341402 Mix 70/30 to NovoMix®3 337 KB
218 Norditropin® 427 KB
219 Lasmiditan 334 KB
220 Typhoid Conjugate vaccine 301 KB
221 Typhoid Conjugate vaccineTCV 299 KB
222 Pharmacokinetic and Pharmacodynamic 476 KB
223 Pharmacokinetics of Murepavadin 248 KB
224 IMU-131 HER2/neu 427 KB
225 Ipatasertib in Combination with Paclitaxel 194 KB
226 Inactivated Japanese Encephalitis Vaccine 451 KB
227 Inactivated poliomyelitis vaccine 12March 149 KB
228 10-valent Pneumococcal Conjugate Vaccine 322 KB
229 Bedaquiline, Delamanid, Linezolid and Clofazimine 267 KB
230 Cetilistat 394 KB
231 Octenidine Dihydrochloride 318 KB
232 Bibrocathol 2% Eye ointment 303 KB
233 Probiotic Supplementation lactic acid bacteria and Bifidobacteria, namely, L. Plantarum DSM24730, L. paracasei DSM 24733, L. delbrueckii subsp. Bulgaricus DSM 24734, L. acidophilus DSM24735, B. longam, DSM24736, B. Infantis DSM 24737, B. breve DSM 24732, and S. thermophilus DSM 24731 which is to be reconstituted with MCT oil drop with Medium Chain Triglyceride (MCT) oil 2042 KB
234 Norethisterone CR tablet 15mg 2068 KB
235 Teneligliptin and Sitagliptin 247 KB
236 secukinumab SUNSHINE 570 KB
237 iGlarLixi versus premixed 321 KB
238 Secukinumab SUNRISE 570 KB
239 Edoxaban tosylate 220 KB
240 Liquid ROTAVAC 5CM (Live Attenuated Rotavirus Vaccine) 277 KB
241 Durvalumab in combination 423 KB
242 Inactivated poliomyelitis vaccine 488 KB
243 Alfuzosin Hydrochloride IP (extended release form) Tadalafil IP film coated tablets (Phase III) 1141 KB
244 Azilsartan Kamedoxomil eq. to Azilsartan Medoxomil Cilnidipine film coated bilayaered tablet (Phase III) 1652 KB
245 Evaluation of Vitamin D Supplementation in affecting the outcome of newly Diagnosed patients with Lymphoma 217 KB
246 Oxaceprol tablet 600mg 1358 KB
247 Tacrolimus lipid suspension 4mg/vial 1294 KB
248 Baricitinib SLE 581 KB
249 Bepotastine besilate JP Montelukast Sodium IP tablets (Phase III) 1067 KB
250 Ivermectin Lotion,0.5% 223 KB
251 Beclomethasone Dipropionate 581 KB
252 Ofatumumab toterability 195 KB
253 Durvalumab Monotherapy 355 KB
254 Phase 3 Relamorelin 413 KB
255 15-Valent Pneumococcal Conjugate Vaccine (PCV15) 322 KB
256 Measles and Rubella Vaccine (Live) 320 KB
257 JHL1101 498 KB
258 Benidipine Hydrochloride IP Telmisartan IP Film coated tablets (Phase III) 1695 KB
259 Rotavirus Vaccine 321 KB
260 Relamorelin gastroparesis 238 KB
261 efficacy ART-123 439 KB
262 Mirabegron (in extended release) Solifenacin Succinate Film coated bilayered tablets (Phase III) 1117 KB
263 SHP640 196 KB
264 Teriflunomide tab 14 mg 428 KB
265 HRF-4467 228 KB
266 Durvalumab plus Olaparib 1481 KB
267 PNB028 266 KB
268 Prednisone delayed Release Tablet 5 mg 2670 KB
269 Itraconazole 1378 KB
270 Enbrel®’ (Etanercept 1379 KB
271 Dexamethasone Sodium Phosphate 1600 KB
272 Durvalumab as Consolidation therapy 1497 KB
273 Relamorelin 1680 KB
274 Single dose Del Nido vs multi dose StThomas II Cardioplegia 235 KB
275 CPL-2009-0031 tablet 140 mg 277 KB
276 Azacitidine 239 KB
277 PMZ-2010 283 KB
278 CPL-2009-0031 tablet 140 mg of Cadila Pharmaceutical Ltd 222 KB
279 Durvalumab 1405 KB
280 LNP3794 in apatients 1411 KB
281 Pembrolizumab 1412 KB
282 Crizanlizumab 1410 KB
283 Dupilumab 1781 KB
284 Ifetroban 1415 KB
285 Herceptin® or TX05 1438 KB
286 Ivabradine Tablets 2291 KB
287 TX05 1595 KB
288 CT-P16 1586 KB
289 tropifexor (LJN452) and cenicriviroc (CVC) 1460 KB
290 Coversin 1489 KB
291 NexoBrid 1513 KB
292 Selinexor (KPT-330 1592 KB
293 PXL01 1568 KB
294 ZS (sodium zirconium cyclosilicate 1636 KB
295 ligelizumab (QGE031) 1696 KB
296 Ligelizumab (QGE031) 1614 KB
297 Cefepime-Tazobactam vs. Meropenem 1484 KB
298 Semaglutide 1601KB
299 Aztreonam-Avibactam (Atm-Avi) 1491 KB
300 Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% 1449 KB
301 Azacitidine 100 mg 280 KB
302 Azelnidipine tab 8 mg / 16 mg 287 KB
303 Epinephrine plus Vasopressin 226KB
304 Saroglitazar Magnesium 17176 KN
305 VELPANAT 197 KB
306 Azelnidipine 371 KB
307 FDC of Efonidipine Hydrochloride Ethanolate + Metoprolol Succinate IP (as extended release) (20 mg+25mg & 20mg+50mg) Film coated tablets. 17177 KB
308 Pregabalin 212 KB
309 Doxycycline 225 KB
310 Bedaquiline, Delamanid, Linezolid and Clofazimine 218 KB
311 Tulobuterol Transdermal 239 KB
312 Enterogermina 179 KB
313 Desidustat ZYAN1 236 KB
314 PMZ-1620 259 KB
315 Nexagon® (NEXAGON) 1530 KB
316 Tapentadol nasal spray 225mg/ml 966 KB
317 Semaglutide 1637 KB
318 Osilodrostat (LCI699 1794 KB
319 Efpeglenatide 444 KB
320 Mirikizumab 1850 KB
321 5-aminolevulinic acid hydrochloride 1845 KB
322 Ticagrelor 1672 KB
323 Edoxaban 1794 KB
324 Brolucizumab 1822 KB
325 Aztreonam-Avibactam (ATM-AVI Pfizer 2029 KB
326 Granexin Gel 545 KB
327 EG12014 1782 KB
328 Mirikizumab 1786 KB
329 Nitazoxanide 500 mg Tablets 1696 KB
330 KAF156 1902 KB
331 LCZ696 1762 KB
332 Esmolol Hydrochloride 14.00% w/w topical gel 1298 KB
333 FDC of Daclatasvir dihydrochloride eq to Daclatasvir 60mg + Sofosbuvir 400mg film coated tablets 1246 KB
334 Clostridium Botulinum Type-A Toxin Haemagglutinin complex injection 300 units 1737 KB
335 Dalfampridine 124 KB
336 Osimertinib 1773 KB
337 Apremilast Tablets 10/20/30mg Phase IV . 1708 KB
338 FDC of Metoprolol Succinate ER + Cilnidipine +Telmisartan (25mg + 10mg + 40mg & 50mg + 10mg + 40mg) Tablets 1300 KB
339 FDC of Metoprolol Tartrate IP + Ivabradine HCL eq to Ivabradine (25mg+5mg & 50mg+5mg) Film coated tablets 1316 KB
340 Mirikizumab 1786 KB
341 LCZ696 1762 KB
342 Edoxaban 1794 KB
343 EG12014 1782 KB
344 Osilodrostat (LCI699 1794 KB
345 Mirikizumab 1850 KB
346 Pilot study on Paracetamol Injection for IM route Pilot study 1593 KB
347 Paracetamol Injection 500mg/2ml for IM route Phase III 1960 KB
348 Bilastine 20 mg 312 KB
349 Magnesium sulfate 116 KB
350 Dolutegravir (Phase IV) 78.6 KB
351 TRC041266 195 KB
352 Nitazoxanide 500 mg Tablets 1696 KB
353 KAF156 1902 KB
354 Scrub Typhus INTREST 1820 KB
355 Granexin Gel 545 KB
356 Aztreonam-Avibactam (ATM-AVI 2029 KB
357 Ticagrelor 1672 KB
358 5-aminolevulinic acid hydrochloride 1854 KB
359 Brolucizumab 1822 KB
360 Tagrisso (Osimertinib) 137 KB
361 Sodium Copper Chlorophyllin 155 KB
362 Kyprolis (Carfilzomib) 184 KB
363 Tadalafil + Dapoxetine (20mg +60mg, 20mg+30mg, 10mg+30mg) film coated tablets (Phase-III). 949 KB
364 Azilsartan Medoxomil + Chlorthalidone (40mg+25mg,40mg+12.5mg 40mg+6.25mg) Tablets (Phase-III). 1,118 KB
365 Alcaftadine 0.25% w/v + Ketoroloc Tromethamine 0.4% w/v Eye drops (Phase-III). 1,163 KB
366 Efonidipine Hydrochloride Ethanolate 20mg + Telmisartan IP 40mg film coated Tablets (Phase-III) 1,008 KB
367 Metoprolol Succinate ER + Chlorthalidone + Telmisartan (50mg+12.5mg+40mg, 25mg+12.5mg+40mg)film coated tablets (Phase-III) 1,027 KB
368 Pregabalin IP (As Prolonged Release) 75mg + Etoricoxib IP 60mg uncoated bilayered tablets (Phase-III). 1,195 KB
369 Semaglutide 2.4 mg 1,708 KB
370 Semaglutide 2.4 mg 1,722 KB
371 emaglutide 2.4 mg CT/18/000019 1,708 KB
372 Filgotinib 1,786 KB
373 Sotagliflozin 1,910 KB
374 Efpeglenatide 444 KB
375 Durvalumab 260 KB
376 Cinacalcet Hydrochloride 1,710 KB
377 Azelnidipine tab 16 mg 130 KB
378 Enzalutamide 98.6 KB
379 Delamanid 82 KB
380 Desidustat 106 KB
381 Calcipotriol/AKVANO 50 µg/g cutaneous solution 1,737,836 KB
382 Efpeglenatide 444 KB
383 Permission for conducting A Phase 3 clinical trial titled "ATLAS- INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX 143KB
384 Permission for conducting a Phase rB/IlA 'clinical study entitled , "A Phase IS /IrA, multi-center , open-label clinical trial to evaluate the safety, to lerability and pharmacokinetic of Desidustat for the patients with Chronic Kidney Disease (CKD) on Dialysis " 97KB
385 Permission for conducting a clinical study entitled "A Phase-l/ll open label, single arm study to evaluate the pharmacokinetic, safety and tolerability of Delamanid in combination with optimized Multidrug Background Regimen (OBR) for multidrug-Resistant Tuberculosis (MDRTB) in HIV infected and HIV-uninfected children with MDR-TB" 76KB
386 Permission for conducting a clinical study entitle d, "A multicentric , Randomized , double blind , parallel group, comparative, Phase 3 clinical study to evaluate the efficacy, Safety and Tolerability of Azelnidipine Tablets 16 mg verus Amlodipine Tablets 10 mg in subjects with essential hypertension " 128KB
387 Ivermectin topical lotion 0.5% w/w 1,858,593 KB
388 Darunavir Tablet 800mg 143KB
389 Permission for conducting a clinical study entitled , "A multicenter Phase-4 , Open-label, Single-arm, Safety and Efficacy Study of Enzalutarnide in Indian Patients with Progressive Metastatic Castration -Resistant Prostate Cancer (mCRPC) Previously Treated with Docetaxel-Based Chemotherapy" 105KB
390 Erdafitinib 1803 KB
391 Canakinumab 1877 KB
392 Rigosertib 1688 KB
393 Paliperidone Palmitate 1757 KB
394 Fitusiran 1875 KB
395 Atezolizumab 1769 KB
396 NexoBrid 302KB
397 Exenatide 373KB
398 YLB113 299KB
399 Rilpivirine 577KB
400 MB02 (Bevacizumab Biosimilar Drug) 573KB
401 Emicizumab 371KB
402 Baricitinib 300KB
403 QAW039 570KB
404 Torsemide Extended Release 568KB
405 Baricitinib 300KB
406 AMG 334 392KB
407 SCY 078 242KB
408 CLS-TA 1814 KB
409 Pimodivir 1718 KB
410 Fitusiran 1758 KB
411 Pimodivir15 1640 KB
412 ASN100 1753 KB
413 MEDI-551 1763 KB
414 Regorafenib 140KB
415 Fluticasone Propionate 100 mcg and Salmeterol 50 mcg 1750 KB
416 QVM149 1804 KB
417 Lenvatinib 143KB
418 Sofosbuvir / Velpatasvir FDC 100KB
419 Februric (Febuxostat) 103KB
420 Pirfenidone 100KB
421 Anagliptin 162KB
422 Verapamil ER 193KB
423 Heptral 105KB
424 Spironolactone cream 5% 926KB
425 Heptral 105kb
426 BIO-11006 565 KB
427 Ataluren 269 KB
428 LUBT010 371 KB
429 ABP 798 340 KB
430 ribociclib with endocrine 423 KB
431 Selinexor (KPT-330) 445 KB
432 Nintedanib Systemic Sclerosis 404 KB
433 Canagliflozin in Children 439 KB
434 Dinutuximab and Irinotecan 456 KB
435 Povidone-Iodine Nail Solution 103 KB
436 SB11 282 KB
437 Atezolizumab compared with chemotherapy 109 KB
438 Lorlatinib (PF-06463922) 470 KB
439 Dapagliflozin 5 and 10 mg 447 KB
440 Denosumab 320 KB
441 CLS-TA Sapphire 100 KB
442 Selinexor 448 KB
443 Bempedoic Acid (ETC-1002) 582 KB
444 LJN452 367 KB
445 Atezolizumab(ANTI-PD-L1Antibody) 907 KB
446 Deferasirox Formulation(Granules) 842 KB
447 Ticagrlor 1115 KB
448 Ruxolitinib 849 KB
449 LCZ696 on NT Pro BNP 1117 KB
450 Alpelisib 861 KB
451 Ixekizumab 1165 KB
452 QAW039 sept 1132 KB
453 PEGylated factor 1154 KB
454 Abemaciclib 1210 KB
455 Apixaban 1104 KB
456 RSV 868 KB
457 Empagliflozin 10mg 1138 KB
458 Empagliflozin 1228 KB
459 LY900014 (Insulin Lispro) 1115 KB
460 Dapagliflozin PC D1699C00001 1064 KB
461 Canagliflozin 1121 KB
462 LNP1892 1018 KB
463 Eltrombopag 867 KB
464 Safety Study of Atezolizumab 814 KB
465 SPI-2012 876 KB
466 ANF-Rho 1125 KB
467 SAIT101 vs Rituximab 1353 KB
468 MOD-4023 1274 KB
469 Dulaglutide 985 KB
470 Ribociclib 846 KB
471 QMF149 150-80 microgram 1039 KB
472 ovidone -Iodine 1133 KB
473 Filgotinib combined phase 1008 KB
474 Secukinumab 888 KB
475 sFilgotinib 1171 KB
476 LNP3794 819 KB
477 Filgotinib Rheumatoid 842 KB
478 Filgotinib Crohn 1203 KB
479 Filgotinib Administered 196 KB
480 LY900014 1048 KB
481 Tenofovir Alafenamide 1111 KB
482 Filgotinib 198 KB
483 Dapagliflozin 1168 KB
484 CLS-TA 59 KB
485 Selonsertib NASH 1326 KB
486 Selonsertib 1320 KB
487 Filgotinib safety 1238 KB
488 Masitinib vs Placebo 807 KB
489 Pemafibrate 1356 KB
490 Ribociclib LEE011 831 KB
491 Bedaquiline 152 KB
492 Daprodustat 183 KB
493 aprodustat 227 KB
494 Oral Semaglutide versus 192 KB
495 LCZ696 145 KB
496 SAIT101 148 KB
497 Alphanate® 139 KB
498 TK-112690 172 KB
499 Clindamycin phosphate 178 KB
500 Etrolizumab 207 KB
501 Ofatumumab safety 186 KB
502 Etrolizumab PhaseII/III 204 KB
503 Pradaxa Capsules 155 KB
504 Ofatumumab 188 KB
505 DE-117 200 KB
506 Lixisenatide 204 KB
507 QVA149 294 KB
508 Aclidinium 229 KB
509 Nintedanib oral 197 KB
510 Sarizotan 142 KB
511 Avelumab 150 KB
512 Insulin Degludec 156 KB
513 CBT124 222 KB
514 Palbociclib 178 KB
515 FIASP 143 KB
516 LY2835219 295 KB
517 Guidance for global access of OCTAMS 1,138kb
518 Guidance Document for Export NOC 137kb
519 Report Book 5,165kb
520 Guidance document for Functions and Responsibilities of Zonal, Sub-zonal & port offices of CDSCO 4,818kb
521 Manual of OCTAMS 4,561kb
522 Sofosbuvir Velpatasvir 158 KB
523 Cardiovascular safety of Oral Semaglutide 216 KB
524 MYL-14020 280 KB
525 Vedolizumab IV 152 KB
526 Budesonide 150 KB
527 Dexamethasone sodium 141 KB
528 Pegylated Interferon @-2a 143 KB
529 NC0195-0092 130 KB
530 Liraglutide 136 KB
531 BCD-055 148 KB
532 QAW039 128 KB
533 Oral Semaglutide 133 KB
534 GS-5745 138 KB
535 RFB002 135 KB
536 Semaglutide IGlar SGT2i 160 KB
537 Trimcinolone Acetonide 173 KB
538 Rivaroxaban 148 KB
539 MEDI4736 aug 211 KB
540 Ceritinib 144 KB
541 MEDI4736 189 KB
542 INC280 2112 KB
543 Ticagrelor 158 KB
544 QMF149 225 KB
545 Indacaterol 277 KB
546 Insulin Aspart 195 KB
547 NW-3509A 153 KB
548 BIASP-30 198 KB
549 Lopinavir/Ritonavir 144 KB
550 MDR-TB Drugs 151 KB
551 Insulin degludec may 216 KB
552 Sofosbuvir 143 KB
553 B1695502 225 KB
554 RLX030 190 KB
555 Clindamycin 189 KB
556 Semaglutide 2016 256 KB
557 Masitinib 178 KB
558 Carbetocin RTS 1542 KB
559 YLB113 184 KB
560 Insulin degludec 245 KB
561 BYL719 189 KB
562 LEE011 183 KB
563 Nintedanib 204 KB
564 Pregabali 182 KB
565 Pregabalin 182 KB
566 Bevacizumab 181 KB
567 Recruitment Rule of Drugs Inspector in CDSCO 2,512kb
568 Alirocumab 191 KB
569 CT P10 186 KB
570 QGE031 S.c 191 KB
571 QGE031 CQGE031B2201 166 KB
572 FG-3019s 190 KB
573 Roxadustat 187 KB
574 Roxadustat Anemia 190 KB
575 Dydrogesterone 178 KB
576 Subcutaneous Secukinumab 221 KB
577 GENA-05 160 KB
578 Pregabalin as adjunctive 171 KB
579 Linaclotide 225 KB
580 LCZ696 NYHA 204 KB
581 LCZ696 Paradigm 235 KB
582 Moroctocog alfa 166 KB
583 RanibizumAB 173 KB
584 Steroids in Iga 181 KB
585 Canagloflozin 209 KB
586 Insulin Aspart BIAsp 201 KB
587 Salmeterol 193 KB
588 Masitinib Lymphoma 189 KB
589 LEE011 NSAI 182 KB
590 Checklist for Test License Appli8cations Effective From 15 June 2011 143kb
591 Guidance Document on Grant of Licenses in Form 11(Test License) 618kb
592 Amended Checklist for test License Applications Effective From 15 June2011 69kb
593 Octafibrin 170 KB
594 DE-109 180 KB
595 ACTG 5288 170 KB
596 Dabigatran etexilate dual 239 KB
597 Clindamycin 1% 215 KB
598 Bococizumab PF-04950615) 368 KB
599 LEE011 with Lerozole 184 KB
600 Bococizumab 369 KB
601 Masitinib Folfiri 209 KB
602 Masitinib 210 KB
603 Dabigatran 197 KB
604 Fibrinogen 182 KB
605 Dabigatran Etexilate 255 KB
606 Chemotherapy 178 KB
607 Rituximab 190 KB
608 2 PARALLEL Masitinib 213 KB
609 Chemoradiation 162 KB
610 Ticagelor 189 KB
611 QGE031 183 KB
612 Isoniazid 172 KB
613 Tiotropium 265 KB
614 Nifedipine Daga 165 KB
615 DS-5565 178 KB
616 Nifedipine Daga 165 KB
617 Labetalol 162 KB
618 LY2963019 200 KB
619 NNC0195-0092 188 KB
620 Insulin Detemir 181 KB
621 Pasireotidestudy 171 KB
622 Pasireotide 173 KB
623 Mifepristone and Misoprotol 163 KB
624 Mifepristone 160 KB
625 LCI699 173 KB
626 Policy Initiatives Planned for 2015 85kb
627 Semaglutide 2014 198 KB
628 LY2605541 200 KB
629 Antidepressant 149 KB
630 Octafibrin GCT/64/14 197 KB
631 Alglucosidase Alfa 164 KB
632 Dabigatran BI 655075 223 KB
633 Ranibizumab VEGF 180 KB
634 Ranibizumab Brilliance 191 KB
635 Ranibizumab CRVO 180 KB
636 Afatinib BiBW 2992 189 KB
637 Trastuzumab 216 KB
638 Afatinib for Patients 172 KB
639 Rituximab RTXM83 185 KB
640 Alglucosidase 171 KB
641 Herpes Zoster 169 KB
642 Pregabalin Adjunctive 188 KB
643 Paclitaxel 178 KB
644 Eravacycline 197 KB
645 UT-15C 176 KB
646 Dapagliflozin 10mg 201 KB
647 UT-15C Phase III 189 KB
648 Bevacizumab AVASTIN 178 KB
649 Pertuzumab 180 KB
650 Pasireotide LAR 163 KB
651 LDK378 219 KB
652 Ifetroban Injection 192 KB
653 FactorVIII 122 KB
654 Baricitinib in Patients 222 KB
655 Adalimumab 179 KB
656 Cyclosporine 190 KB
657 Fluocinolone acetonide intravitreal 174 KB
658 Ranibizumab 0.5 mg 188 KB
659 Everolimus with reduced calcineurin 256 KB
660 Fosaprepitant 191 KB
661 Liraglutide Sitagliptin 181 KB
662 Masitinib 198 KB
663 Sitagliptin 213 KB
664 NOVA22007 191 KB
665 QAW039 on FEV1 184 KB
666 Clindamycin benzoyal peroxide 265 KB
667 BCD-020 223 KB
668 Pasireotide S.C 173 KB
669 Ciprodex 212 KB
670 Daclizumab 186 KB
671 Enbrel 194 KB
672 Remicade 215 KB
673 Exenatide 174 KB
674 Ceftazidime CAZ AVI 200 KB
675 Buparlisib 182 KB
676 BCD-021 214 KB
677 Insulin Degludec versus insulin glargine 277 KB
678 Liraglutide versus sulphonylurea 211 KB
679 BCD-022 217 KB
680 tolerability of Secukinumab 176 KB
681 Everolimus alone 183 KB
682 Everolimus RADOO1 192 KB
683 Transfer Policy 421kb
684 SAR236553 681 KB
685 Afatinib 225 KB
686 subcutaneous Secukinumab 166 KB
687 Sofosbuvir plus ribavirin 291 KB
688 Everolimus 243 KB
689 Fluocinolone 292 KB
690 Ceftazidime 283 KB
691 FLU D-QIV 278 KB
692 FIAsP 2014 279 KB
693 FIAsP Insulin 280 KB
694 Tenofovir Disoproxil 303 KB
695 Tenofovir Alafenamide TAF 314 KB
696 olasertib 289 KB
697 Baricitinib 357 KB
698 Diclofenac Gel 370 KB
699 Baricitinib LY3009104 348 KB
700 TechnologyMG145 1410 KB
701 BEZ235 846 KB
702 Producttrastuzumab 926 KB
703 LAF237 293 KB
704 Liraglutide sc Injection 306 KB
705 Fesoterodine 305 KB
706 Human rh FV III 301 KB
707 CP-690,550 296 KB
708 Octefibrin 290 KB
709 Tenofovir 342 KB
710 Lixisenatid Subcutaneous 382 KB
711 ART-123 303 KB
712 Quotation of rate contract for supply of Photostat Paper (JK Brand) Last date (27 Jul 2012 ) 129kb
713 Re-tendering for Housekeeping and General cleanliness in the CDSCO(HQ), FDA Bhawan, Kotla Road, New Delhi Last Date ( 27 Jul 2012 ) 903kb
714 Extension of Date of Notice Inviting Tender (NIT) Last Date( 27 Jul 2012 ) 370kb
715 Annual Rate Contract for Hiring taxies 1 Last Date( 27 Jul 2012 ) 132kb
716 Annual Rate Contract for Hiring taxies 2 Last Date ( 27 Jul 2012 ) 1,775kb
717 Annual Rate Contract for Hiring taxies 3 Last Date( 27 Jul 2012 ) 162kb