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 Reversible Inhibition of Sperm under Guidance (RISUG) 227 KB
3 Desidustat 285 KB
4 PNB-001 10107 KB
5 HRF-10071 tab 226 KB
6 Bosutinib tab 292 KB
7 Epinephrine Sublingual tab 202 KB
8 2'0 Methyl Antisense Oligonucleotide 290 KB
9 Azelnidipine 8 mg plus Metoprolol Succinate ER 50 mg tab and Azelnidipine 16 mg plus Metoprolol Succinate ER 50 mg tab 13899 KB
10 Trastuzumab Deruxtecan 491 KB
11 Capaivasertib+Abiraterone 331 KB
12 PF-06865571 377 KB
13 TRC041266 10239 KB
14 Inosine Pranobex 500 mg 11600 KB
15 Mirikizumab 259 KB
16 Desidustat tab 11490 KB
17 PF-06826647 260 KB
18 Secukinumabd 257 KB
19 Erenumab 497 KB
20 Netarsudil Ophthalmic sol 0.02%`w/v 13846 KB
21 Perampanel 305 KB
22 Trenexamic Acid 257 KB
23 Pregabalin ER 194 KB
24 Dacomitinib tab 15 rm 234 KB
25 Gemcitabine 367 KB
26 Fitusiran 475 KB
27 SCD411 And Eylea 502 KB
28 Gepotidacin 483 KB
29 Brolucizumab 312 KB
30 Lorlatinib tab 25 rmg 241 KB
31 ct Umifenovir Hcl cap 1833 KB
32 VIB4920 318 KB
33 Somapacitan 493 KB
34 Pirfenidone 267 mg tab 1675 KB
35 Topiroxostat tablets 20 mg/40mg/60 mg 248 KB
36 Naftifine Hydrochloride Gel 2% 232 KB
37 Dienogest (Ph IV) 254 KB
38 Hydrocorticosone Acetate 379 KB
39 PF-06480605 377 KB
40 Acodiamide Hydrochloride 300 mg 1873 KB
41 Lipoprotein 674 KB
42 C21 509 KB
43 Acalabrutinib 399 KB
44 Umifenovir 2588 KB
45 Sphaeranthus Indicus Extract 2203 KB
46 Benidipine Hydrochloride + Chlorthalidone IP Film coated tablets (Phase III) 273 KB
47 Hepcidin Mimetic PTG-300 496 KB
48 Colloidal silver BP 50 ppm 12437 KB
49 BDB001 236 KB
50 IIIM-290 942 KB
51 Azacitidine 250 KB
52 Ulinastatin for Injection 1431 KB
53 ZYBK2 9991 KB
54 Nafamostat Mesilate for inj 11361 KB
55 Favipiravir & Umifenovir 12027 KB
56 2-Deoxy-D-Glucose (2-DG) 240 KB
57 NitazoxanideTablet 500 mgHydroxychloroquine Tablet 200 mg 1361 KB
58 Cocculus hirsutus 1154 KB
59 Favipiravir 12309 KB
60 NitazoxanideTabet 500 mg and Hydroxychloroquine Tablet 200 mg 1456 KB
61 Dustasteride Topical solution 0.01% w/v, 0.02% w/v and 0.005% w/v 679 KB
62 Sotagliflozin 534 KB
63 PIK3CA 296 KB
64 Favipiravir 2366 KB
65 Remdesevir (GS-5734) for inj 100 mg 1914 KB
66 Osimertinib 399 KB
67 S.C. Secukinumab 360 KB
68 VIS649 375 KB
69 Concizumab 497 KB
70 CPI-613 498 KB
71 lumasiran 493 KB
72 Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium +Cilnidipine IP Film coated tablets (Phase III) 309 KB
73 CA-170 234 KB
74 vaporized cannabinoids 225 KB
75 5-aminolevulinic Acid 384 KB
76 DE-109 258 KB
77 Canagliflozin + Metformin HCl Film coated tablets (Phase IV) 216 KB
78 Intravenous Secukinimab 497 KB
79 Glycopyrrolate IP eq. to Glycopyrronium + Arformoterol Tartrate eq. to Arformoterol Inhalation solution (Phase III) 303 KB
80 Oral Pharmacokinetics and Safety of TRC041266 Powder with TRC4186 Tablet 195 KB
81 Bilastine + Montelukast Sodium IP eq. to Montelukast Film coated tablets 288 KB
82 Secukinumab 497 KB
83 Tirzepatide 518 KB
84 Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Chlorthalidone IP Film coated tablets (Phase III) 336 KB
85 Inactivated Hepatitis A vaccine 281 KB
86 Selpercatinib 491 KB
87 ZYBK2 206 KB
88 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
89 Cabozantinib or Vandetanib 419 KB
90 Estradiol Valerate 4mg SR Table 1773 KB
91 Pregabalin IP + Duloxetine Hydrochloride IP eq. to Duloxetine (as delayed release pellets) hard gelatin capsules (Phase III) 248 KB
92 Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Chlorthalidone IP Film coated tablets (Phase III) 318 KB
93 Evenamide (NW-3509)2 269 KB
94 AR-301 251 KB
95 Tirzepatide 256 KB
96 Evenamide2 379 KB
97 Bedaquiline, Delamanid 360 KB
98 Bedaquiline Tablets 100mg 255 KB
99 Dienogest (Visanne®) 196 KB
100 Tropifexor (LJN452) & licogliflozin 429 KB
101 Hydroxychloroquine Sulfate Tablet 200mg/300 mg 788 KB
102 Goserelin 10.8mg Injection1 1460 KB
103 Hydrocortisone Acetate Suppositories, 25 Mg 303 KB
104 Ipatasertib 505 KB
105 Inactivated Therapeutic Tuberculosis Vaccine 185 KB
106 Fingolimod capsule 2608 KB
107 Glimepiride IP + Voglibose IP + Metformin HCl IP (as ER) uncoated bilayered tablet (Phase IV) 242 KB
108 Remogliflozin Etabonate + Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin Film coated tablets (Phase III) 302 KB
109 Silodosin + Solifenacin Succinate Ph. Eur. Capsule (Phase III) 337 KB
110 Mirabegron + Solifenacin Succinate tablets (Phase III) 232 KB
111 Ivabradin Tablet 2543 KB
112 sacubitril/valsartan 251 KB
113 Goserelin 10.8mg Injection 381 KB
114 Bilastine + Montelukast Sodium IP eq. to Montelukast uncoated tablet (Phase III) 297 KB
115 Brimonidine Tartrate 0.1% Ophthalmic Solution 325 KB
116 Selonsertib 1460 KB
117 Evenamide(NW-3509/008/II/2019) 375 KB
118 PF-06741086 493 KB
119 Remogliflozin Etabonate Vildagliptin film coated tablet 1222 KB
120 Capmatinib 249 KB
121 Hydrocortisone Acetate 358 KB
122 Cephalexin extended release Clavulanate Potassium tablet 1016 KB
123 Ripasudil HCl Hydrate eq. To Ripasudil Timolol Maleate IP Eq. To to Timolol eye drops 1008 KB
124 Goserelin 3.6 mg Injection 495 KB
125 Ceftazidime 321 KB
126 Triamcinolone acetonide IP Lignocaine HCl IP Gel 712 KB
127 Ceftazidime-Avibactam 489 KB
128 GSK2831781 502 KB
129 Gepotidacin 256 KB
130 Lipidol 3028 KB
131 Evenamide(NW-3509/006/III/2019) 509 KB
132 Evenamide(nw-3509) 509 KB
133 Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze Dried) 193 KB
134 Prohance® (Gadoteridol 279.3 mg/mllnjection 2667 KB
135 Dalbavancin 2754 KB
136 opivacaine Hydrochloride USP eq. to anhydrous Ropivacaine hydrochloride Dextrose IP per ml injection 959 KB
137 Azelnidipine Olmesartan Medoxomil IP tablets 1260 KB
138 Benidipine HCl Chlorthalidone IPTelmisartan IP Film coated bilayered tablets 876 KB
139 Rosuvastatin IP Teneligliptin Film coated tablet 1099 KB
140 SB3 249 KB
141 International Centre for Genetic Engineering and Biotechnology CampusBivalent (JAIVAC-2: PfMSPFu24 +PfF2/ Alhydrogel) P. falciparum malaria vaccine 167 KB
142 Baricitinib eli lily 509 KB
143 TRUNCATE – TB (tuberculosis) 3884 KB
144 Lenvatinib Capsules 4 mg and 10 mg 330 KB
145 Azilsartan KamedoxomilChlorthalidone IP tablet 654 KB
146 Ticagrelor 120/180 mg SR Tablet 2652 KB
147 AUR101 3310 KB
148 AUR101 3310 KB
149 Diptheria,Tetanus, Pertussis (Whole cell),Hepatitis B, Poliomyelitis (inactivated) and Haemophilus Influenzae Type b conjugate Vaccine (Adsorbed) [DTwPHepB-IPV-Hib vaccine (Adsorbed 207 KB
150 Desidustat Tablet versus Epoetin alfa Injection 2558 KB
151 Recombinant Hepatitis E Vaccine, Single Human Dose 266 KB
152 PNB-001 267 KB
153 Zileuton Ointment 1.25% and 5.0% 702 KB
154 FEIBA 403 KB
155 Inactivated Hepatitis A Vaccine (Adsorbed) I.P.6nov 262 KB
156 Etrasimod 485 KB
157 Brazikumab 491 KB
158 Inotuzumab 370 KB
159 Etrasimod( IQVIA) 502 KB
160 Iodixanol 2023 KB
161 LNP023 366 KB
162 Concizumab Prophylaxis 508 KB
163 Concizumab 327 KB
164 LNP023(Rituximab) 260 KB
165 Oral Baricitinib 503 KB
166 Avanafil tablets 100 mg & 200 mg 1223 KB
167 Etrasimod( IQVIA RDS) 513 KB
168 CT-P13 471 KB
169 Ruxolitinib 310 KB
170 Ruxolitinib 310 KB
171 GSK3196165 284 KB
172 Spironolactone Topical Cream 5% 1495 KB
173 Apremilast Film Coated 10/10/30mg Tablets 2755 KB
174 Tenofovir Alafenamide, Emtricitabine and Bictegravir 2682 KB
175 Sofosbuvir 400 mg Tablet 2627 KB
176 Typhoid Vi conjugate VaccineRa 276 KB
177 Cilnidipine IP Azilsartan Kamedoxomil eq. to Azilsartan Medoxomil tablets 609 KB
178 Benidipine HCl IPTelmisartan IP Film coated tablets 641 KB
179 Azelnidipine Telmisartan tablets 624 KB
180 Typhoid Vi conjugate Vaccine30sep 185 KB
181 Methylcobalamin Nasal spray 500 mcg 284 KB
182 Certican / Zortress(everolimus EVR) 312 KB
183 Tirzepatide1 313 KB
184 Tirzepatide 313 KB
185 QL1205 Versus Lucentis 304 KB
186 HP-hMG and Menopur® 2143 KB
187 Bupivacaine Hydrochloride IP eq. to anhydrous Bupivacaine Hydrochloride Fentanyl Citrate IP Eq. to Fentanyl injection 672 KB
188 AT-10 (2-oxoclopidogrel bisulfate 2845 KB
189 Inactivated Hepatitis A vaccine (Adsorbed) I.P. 187 KB
190 Brazikumab 393 KB
191 Rabies Vaccine, Human, I.P. 187 KB
192 semaglutide versus placebo 477 KB
193 evenamide or placebo 273 KB
194 Ribociclib plus goserelin acetate 434 KB
195 Meningococcal Conjugate Vaccine 510 KB
196 Leuprolide acetate 2291 KB
197 ligelizumab (QGE031) 328 KB
198 MYL-1701P and Eylea 299 KB
199 Netarsudil Ophthalmic solution 0.02% 3055 KB
200 Montelukast sodium eq. to Montelukast IP + Bilastine film coated tablet (Phase III Clinical Trial) 710 KB
201 Montelukast sodium eq. to Montelukast IP + Bilastine film coated tablet (Phase III Clinical Trial) 710 KB
202 Montelukast sodium eq. to Montelukast IP + Bilastine film coated tablet (Phase III Clinical Trial) 710 KB
203 Efonidipine Hydrochloride Ethanolate + Telmisartan IP + Chlorthalidone IP Tablets (Phase III Clinical Trial 705 KB
204 Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Cilnidipine IP film coated tablet (Phase III Clinical Trial) 697 KB
205 Mirikizumab 625 KB
206 Menopausal Gonadotropin 2618 KB
207 Tranexamic acid 1667 KB
208 Azelnidipine IP + Chlorthalidone IP Uncoated Tablet (Phase III Clinical Trial) 617 KB
209 Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-Valent) 259 KB
210 baloxavir marboxil 492 KB
211 k0706 592 KB
212 Mirikizumab (UC) 625 KB
213 Semaglutide 2366 KB
214 traconazole 1373 KB
215 Semaglutide (SOUL) 2366 KB
216 Filgotinib (rheumatoid Arthritis) 519 KB
217 Filgotinib 591 KB
218 Fluticasone Propionate + Salmeterol inhalation Powder (Phase III Clinical Trial) 531 KB
219 Fluticasone Propionate + Salmeterol inhalation Powder (Phase III Clinical Trial) 531 KB
220 Tigilanol Tiglate 368 KB
221 Capivasertib + Paclitaxel versus placebo 228 KB
222 Oral Baricitinib 316 KB
223 Baricitinib 500 KB
224 HD204 to Avastin® 513 KB
225 Baricitinib 500 KB
226 Evenamide 608 KB
227 Beclomethasone 1765 KB
228 Aceclofenac Topical ointment 1.5% w/wIII 2285 KB
229 Evenamide 608 KB
230 Ulipristal acetate tablet 30mgIII 2555 KB
231 IVIEW-1201 264 KB
232 Sertaconazole Nitrate + Terbinafine HCl cream (Phase III Clinical Trial) 643 KB
233 INTP24 against Avastin® in 468 KB
234 Ribiciclib 289 KB
235 PMZ-1620 320 KB
236 PMZ-1620 320 KB
237 Adenosine IP + Minoxidil IP Topical solution (Phase II Clinical Trial) 626 KB
238 Benidipine Hydrochloride + Metoprolol Succinate eq. to Metoprolol tartrate IP Film coated tablet (Phase III Clinical Trial) 357 KB
239 Benidipine Hydrochloride JP + Chlorthalidone IP Film coated tablets (Phase III Clinical Trial 580 KB
240 AS012 230 KB
241 Lenalidomide 267 KB
242 Osimertinib in Combination with Savolitinib 492 KB
243 Crizanlizumab 303 KB
244 Biapenem 300 mg inj 368 KB
245 Saroglitazar tablet 4mg II 2058 KB
246 Sulbactam-ETX2514 427 KB
247 Rifapentine plus Isoniazid 259 KB
248 Recombinant Hepatitis E Vaccine 155 KB
249 Toujeo 300 Units/ml 486 KB
250 IQVIA 213 KB
251 Ropivacaine Readyfusor 2mg/mlIII 2629 KB
252 Acotiamide ER tablet 300 tabletIII 2090 KB
253 Oral Galactose 252 KB
254 Vi-capsular Polysaccharide-CRM197 Conjugate Typhoid Vaccine 284 KB
255 Semaglutide (NN9535-4352) 429 KB
256 Guselkumab 566 KB
257 Semaglutide 429 KB
258 Curcumin (Biocurcumax cap) as an adjunct drug to standard therapy [(Artesunate) + (Sulfadoxine-Pyrimethamine) tablet] 238 KB
259 Pneumococcal polysaccharide conjugate vaccine (14-valent) 283 KB
260 2Ó-Methyl-Phosphorothioate Anti Sense Oligoribonucleotide for treating patients with Duchenne Muscular Dystrophy 231 KB
261 Typhoid Vi Conjugate Vaccine 280 KB
262 Xlucane versus Lucentis® 443 KB
263 Durvalumab 427 KB
264 Neoadjuvant/adjuvantDurvalumab 427 KB
265 Rituximab Biosimilar (DRL_RI) with MabThera® 434 KB
266 Tirzepatide 432 KB
267 Baricitinib 194 KB
268 Phenobarbital Sodium Injection 191 KB
269 METREXASSIST™ 194 KB
270 FDC of Daclatasvir Dihydrochloride Eq. to Daclatasvir 60mg Sofosbuvir 400mg film coated tablets (Phase IV) 1031 KB
271 C.O.M.B.A.T 222 KB
272 Sodium Fusidate eq. To Fusidic acid 2% w/w (Sofinox gel) 3105 KB
273 Saroglitazar 2mg & 4mg Tablet 2767 KB
274 esidustat vs Darbepoetin 295 KB
275 Rivaroxaban tablets 2.5mg (Xarelto®) 2579 KB
276 TRC160334 295 KB
277 Tacrolimus lipid tablet 3mg 2677 KB
278 Oral Nafithromycin vs oral Moxifloxacin 417 KB
279 Olaparib 250 KB
280 Typhoid Conjugate vaccineApril11 301 KB
281 Fitusira 419 KB
282 SB12 and Soliris 202 KB
283 Galcanezumab 327 KB
284 SAR341402 Mix 70/30 to NovoMix®3 337 KB
285 Durvalumab 208 KB
286 Norditropin® 427 KB
287 Lasmiditan 334 KB
288 Typhoid Conjugate vaccine 301 KB
289 Typhoid Conjugate vaccineTCV 299 KB
290 Pharmacokinetic and Pharmacodynamic 476 KB
291 Pharmacokinetics of Murepavadin 248 KB
292 IMU-131 HER2/neu 427 KB
293 Ipatasertib in Combination with Paclitaxel 194 KB
294 Inactivated Japanese Encephalitis Vaccine 451 KB
295 Inactivated poliomyelitis vaccine 12March 149 KB
296 10-valent Pneumococcal Conjugate Vaccine 322 KB
297 Bedaquiline, Delamanid, Linezolid and Clofazimine 267 KB
298 Octenidine Dihydrochloride 318 KB
299 Cetilistat 394 KB
300 Bibrocathol 2% Eye ointment 303 KB
301 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
302 Norethisterone CR tablet 15mg 2068 KB
303 Teneligliptin and Sitagliptin 247 KB
304 secukinumab SUNSHINE 570 KB
305 iGlarLixi versus premixed 321 KB
306 Edoxaban tosylate 220 KB
307 Secukinumab SUNRISE 570 KB
308 Inactivated poliomyelitis vaccine 488 KB
309 Durvalumab in combination 423 KB
310 Liquid ROTAVAC 5CM (Live Attenuated Rotavirus Vaccine) 277 KB
311 Alfuzosin Hydrochloride IP (extended release form) Tadalafil IP film coated tablets (Phase III) 1141 KB
312 Azilsartan Kamedoxomil eq. to Azilsartan Medoxomil Cilnidipine film coated bilayaered tablet (Phase III) 1652 KB
313 Evaluation of Vitamin D Supplementation in affecting the outcome of newly Diagnosed patients with Lymphoma 217 KB
314 Oxaceprol tablet 600mg 1358 KB
315 Tacrolimus lipid suspension 4mg/vial 1294 KB
316 Baricitinib SLE 581 KB
317 Durvalumab Monotherapy 355 KB
318 Beclomethasone Dipropionate 581 KB
319 Ivermectin Lotion,0.5% 223 KB
320 Bepotastine besilate JP Montelukast Sodium IP tablets (Phase III) 1067 KB
321 Ofatumumab toterability 195 KB
322 15-Valent Pneumococcal Conjugate Vaccine (PCV15) 322 KB
323 Phase 3 Relamorelin 413 KB
324 JHL1101 498 KB
325 Benidipine Hydrochloride IP Telmisartan IP Film coated tablets (Phase III) 1695 KB
326 Measles and Rubella Vaccine (Live) 320 KB
327 Rotavirus Vaccine 321 KB
328 efficacy ART-123 439 KB
329 Relamorelin gastroparesis 238 KB
330 Mirabegron (in extended release) Solifenacin Succinate Film coated bilayered tablets (Phase III) 1117 KB
331 SHP640 196 KB
332 Teriflunomide tab 14 mg 428 KB
333 PNB028 266 KB
334 Durvalumab plus Olaparib 1481 KB
335 HRF-4467 228 KB
336 Itraconazole 1378 KB
337 Prednisone delayed Release Tablet 5 mg 2670 KB
338 Dexamethasone Sodium Phosphate 1600 KB
339 Durvalumab as Consolidation therapy 1497 KB
340 Relamorelin 1680 KB
341 Enbrel®’ (Etanercept 1379 KB
342 Single dose Del Nido vs multi dose StThomas II Cardioplegia 235 KB
343 PMZ-2010 283 KB
344 CPL-2009-0031 tablet 140 mg 277 KB
345 CPL-2009-0031 tablet 140 mg of Cadila Pharmaceutical Ltd 222 KB
346 Azacitidine 239 KB
347 Durvalumab 1405 KB
348 LNP3794 in apatients 1411 KB
349 Pembrolizumab 1412 KB
350 Crizanlizumab 1410 KB
351 Dupilumab 1781 KB
352 Ifetroban 1415 KB
353 Ivabradine Tablets 2291 KB
354 TX05 1595 KB
355 CT-P16 1586 KB
356 Herceptin® or TX05 1438 KB
357 tropifexor (LJN452) and cenicriviroc (CVC) 1460 KB
358 Semaglutide 1601KB
359 ligelizumab (QGE031) 1696 KB
360 NexoBrid 1513 KB
361 ZS (sodium zirconium cyclosilicate 1636 KB
362 Coversin 1489 KB
363 Selinexor (KPT-330 1592 KB
364 Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% 1449 KB
365 Aztreonam-Avibactam (Atm-Avi) 1491 KB
366 Ligelizumab (QGE031) 1614 KB
367 Cefepime-Tazobactam vs. Meropenem 1484 KB
368 PXL01 1568 KB
369 Azacitidine 100 mg 280 KB
370 Epinephrine plus Vasopressin 226KB
371 Azelnidipine tab 8 mg / 16 mg 287 KB
372 Saroglitazar Magnesium 17176 KN
373 Azelnidipine 371 KB
374 VELPANAT 197 KB
375 FDC of Efonidipine Hydrochloride Ethanolate + Metoprolol Succinate IP (as extended release) (20 mg+25mg & 20mg+50mg) Film coated tablets. 17177 KB
376 Pregabalin 212 KB
377 Doxycycline 225 KB
378 Bedaquiline, Delamanid, Linezolid and Clofazimine 218 KB
379 Desidustat ZYAN1 236 KB
380 PMZ-1620 259 KB
381 Enterogermina 179 KB
382 Tulobuterol Transdermal 239 KB
383 Nexagon® (NEXAGON) 1530 KB
384 Tapentadol nasal spray 225mg/ml 966 KB
385 Semaglutide 1637 KB
386 Nitazoxanide 500 mg Tablets 1696 KB
387 Edoxaban 1794 KB
388 EG12014 1782 KB
389 Mirikizumab 1786 KB
390 LCZ696 1762 KB
391 Ticagrelor 1672 KB
392 5-aminolevulinic acid hydrochloride 1845 KB
393 Brolucizumab 1822 KB
394 Aztreonam-Avibactam (ATM-AVI Pfizer 2029 KB
395 Granexin Gel 545 KB
396 KAF156 1902 KB
397 Efpeglenatide 444 KB
398 Mirikizumab 1850 KB
399 Osilodrostat (LCI699 1794 KB
400 Esmolol Hydrochloride 14.00% w/w topical gel 1298 KB
401 FDC of Daclatasvir dihydrochloride eq to Daclatasvir 60mg + Sofosbuvir 400mg film coated tablets 1246 KB
402 Clostridium Botulinum Type-A Toxin Haemagglutinin complex injection 300 units 1737 KB
403 Dalfampridine 124 KB
404 Osimertinib 1773 KB
405 Apremilast Tablets 10/20/30mg Phase IV . 1708 KB
406 FDC of Metoprolol Tartrate IP + Ivabradine HCL eq to Ivabradine (25mg+5mg & 50mg+5mg) Film coated tablets 1316 KB
407 FDC of Metoprolol Succinate ER + Cilnidipine +Telmisartan (25mg + 10mg + 40mg & 50mg + 10mg + 40mg) Tablets 1300 KB
408 Edoxaban 1794 KB
409 EG12014 1782 KB
410 Mirikizumab 1786 KB
411 LCZ696 1762 KB
412 Mirikizumab 1850 KB
413 Osilodrostat (LCI699 1794 KB
414 Paracetamol Injection 500mg/2ml for IM route Phase III 1960 KB
415 Pilot study on Paracetamol Injection for IM route Pilot study 1593 KB
416 Bilastine 20 mg 312 KB
417 Magnesium sulfate 116 KB
418 Dolutegravir (Phase IV) 78.6 KB
419 TRC041266 195 KB
420 Ticagrelor 1672 KB
421 5-aminolevulinic acid hydrochloride 1854 KB
422 Brolucizumab 1822 KB
423 Aztreonam-Avibactam (ATM-AVI 2029 KB
424 Granexin Gel 545 KB
425 Nitazoxanide 500 mg Tablets 1696 KB
426 Scrub Typhus INTREST 1820 KB
427 KAF156 1902 KB
428 Tagrisso (Osimertinib) 137 KB
429 Sodium Copper Chlorophyllin 155 KB
430 Kyprolis (Carfilzomib) 184 KB
431 Tadalafil + Dapoxetine (20mg +60mg, 20mg+30mg, 10mg+30mg) film coated tablets (Phase-III). 949 KB
432 Azilsartan Medoxomil + Chlorthalidone (40mg+25mg,40mg+12.5mg 40mg+6.25mg) Tablets (Phase-III). 1,118 KB
433 Alcaftadine 0.25% w/v + Ketoroloc Tromethamine 0.4% w/v Eye drops (Phase-III). 1,163 KB
434 Efonidipine Hydrochloride Ethanolate 20mg + Telmisartan IP 40mg film coated Tablets (Phase-III) 1,008 KB
435 Metoprolol Succinate ER + Chlorthalidone + Telmisartan (50mg+12.5mg+40mg, 25mg+12.5mg+40mg)film coated tablets (Phase-III) 1,027 KB
436 Pregabalin IP (As Prolonged Release) 75mg + Etoricoxib IP 60mg uncoated bilayered tablets (Phase-III). 1,195 KB
437 emaglutide 2.4 mg CT/18/000019 1,708 KB
438 Durvalumab 260 KB
439 Efpeglenatide 444 KB
440 Semaglutide 2.4 mg 1,722 KB
441 Semaglutide 2.4 mg 1,708 KB
442 Cinacalcet Hydrochloride 1,710 KB
443 Filgotinib 1,786 KB
444 Sotagliflozin 1,910 KB
445 Desidustat 106 KB
446 Delamanid 82 KB
447 Enzalutamide 98.6 KB
448 Azelnidipine tab 16 mg 130 KB
449 Calcipotriol/AKVANO 50 µg/g cutaneous solution 1,737,836 KB
450 Efpeglenatide 444 KB
451 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
452 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
453 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
454 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
455 Ivermectin topical lotion 0.5% w/w 1,858,593 KB
456 Darunavir Tablet 800mg 143KB
457 Erdafitinib 1803 KB
458 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
459 Canakinumab 1877 KB
460 Paliperidone Palmitate 1757 KB
461 Rigosertib 1688 KB
462 Atezolizumab 1769 KB
463 Fitusiran 1875 KB
464 MB02 (Bevacizumab Biosimilar Drug) 573KB
465 SCY 078 242KB
466 Exenatide 373KB
467 YLB113 299KB
468 Rilpivirine 577KB
469 Emicizumab 371KB
470 NexoBrid 302KB
471 Baricitinib 300KB
472 QAW039 570KB
473 Torsemide Extended Release 568KB
474 Baricitinib 300KB
475 AMG 334 392KB
476 Pimodivir15 1640 KB
477 Fitusiran 1758 KB
478 Pimodivir 1718 KB
479 CLS-TA 1814 KB
480 ASN100 1753 KB
481 MEDI-551 1763 KB
482 Regorafenib 140KB
483 Fluticasone Propionate 100 mcg and Salmeterol 50 mcg 1750 KB
484 QVM149 1804 KB
485 Lenvatinib 143KB
486 Sofosbuvir / Velpatasvir FDC 100KB
487 Februric (Febuxostat) 103KB
488 Pirfenidone 100KB
489 Anagliptin 162KB
490 Verapamil ER 193KB
491 Heptral 105KB
492 Spironolactone cream 5% 926KB
493 Heptral 105kb
494 BIO-11006 565 KB
495 LUBT010 371 KB
496 Ataluren 269 KB
497 ribociclib with endocrine 423 KB
498 Selinexor (KPT-330) 445 KB
499 Nintedanib Systemic Sclerosis 404 KB
500 ABP 798 340 KB
501 Dapagliflozin 5 and 10 mg 447 KB
502 Atezolizumab compared with chemotherapy 109 KB
503 SB11 282 KB
504 Dinutuximab and Irinotecan 456 KB
505 Povidone-Iodine Nail Solution 103 KB
506 Canagliflozin in Children 439 KB
507 Lorlatinib (PF-06463922) 470 KB
508 Denosumab 320 KB
509 CLS-TA Sapphire 100 KB
510 Selinexor 448 KB
511 Bempedoic Acid (ETC-1002) 582 KB
512 LJN452 367 KB
513 Atezolizumab(ANTI-PD-L1Antibody) 907 KB
514 Deferasirox Formulation(Granules) 842 KB
515 Ticagrlor 1115 KB
516 Ruxolitinib 849 KB
517 LCZ696 on NT Pro BNP 1117 KB
518 Alpelisib 861 KB
519 Ixekizumab 1165 KB
520 QAW039 sept 1132 KB
521 PEGylated factor 1154 KB
522 Abemaciclib 1210 KB
523 Apixaban 1104 KB
524 RSV 868 KB
525 Empagliflozin 10mg 1138 KB
526 Empagliflozin 1228 KB
527 LY900014 (Insulin Lispro) 1115 KB
528 Dapagliflozin PC D1699C00001 1064 KB
529 QMF149 150-80 microgram 1039 KB
530 Eltrombopag 867 KB
531 Ribociclib 846 KB
532 Safety Study of Atezolizumab 814 KB
533 Dulaglutide 985 KB
534 SPI-2012 876 KB
535 ANF-Rho 1125 KB
536 MOD-4023 1274 KB
537 ovidone -Iodine 1133 KB
538 SAIT101 vs Rituximab 1353 KB
539 LNP1892 1018 KB
540 Canagliflozin 1121 KB
541 Filgotinib Crohn 1203 KB
542 LNP3794 819 KB
543 Filgotinib combined phase 1008 KB
544 sFilgotinib 1171 KB
545 Secukinumab 888 KB
546 Filgotinib Rheumatoid 842 KB
547 Filgotinib Administered 196 KB
548 LY900014 1048 KB
549 Tenofovir Alafenamide 1111 KB
550 Filgotinib 198 KB
551 Dapagliflozin 1168 KB
552 CLS-TA 59 KB
553 Masitinib vs Placebo 807 KB
554 Selonsertib 1320 KB
555 Filgotinib safety 1238 KB
556 Ribociclib LEE011 831 KB
557 Pemafibrate 1356 KB
558 Selonsertib NASH 1326 KB
559 Bedaquiline 152 KB
560 Daprodustat 183 KB
561 aprodustat 227 KB
562 Oral Semaglutide versus 192 KB
563 LCZ696 145 KB
564 SAIT101 148 KB
565 Alphanate® 139 KB
566 TK-112690 172 KB
567 Pradaxa Capsules 155 KB
568 Etrolizumab PhaseII/III 204 KB
569 Ofatumumab safety 186 KB
570 Ofatumumab 188 KB
571 Etrolizumab 207 KB
572 Clindamycin phosphate 178 KB
573 DE-117 200 KB
574 Lixisenatide 204 KB
575 QVA149 294 KB
576 Aclidinium 229 KB
577 Nintedanib oral 197 KB
578 Sarizotan 142 KB
579 Insulin Degludec 156 KB
580 Avelumab 150 KB
581 Palbociclib 178 KB
582 FIASP 143 KB
583 CBT124 222 KB
584 LY2835219 295 KB
585 Guidance Document for Export NOC 137kb
586 Guidance for global access of OCTAMS 1,138kb
587 Guidance document for Functions and Responsibilities of Zonal, Sub-zonal & port offices of CDSCO 4,818kb
588 Manual of OCTAMS 4,561kb
589 Report Book 5,165kb
590 Sofosbuvir Velpatasvir 158 KB
591 Cardiovascular safety of Oral Semaglutide 216 KB
592 MYL-14020 280 KB
593 Budesonide 150 KB
594 Vedolizumab IV 152 KB
595 Dexamethasone sodium 141 KB
596 Pegylated Interferon @-2a 143 KB
597 Liraglutide 136 KB
598 NC0195-0092 130 KB
599 BCD-055 148 KB
600 QAW039 128 KB
601 Oral Semaglutide 133 KB
602 GS-5745 138 KB
603 RFB002 135 KB
604 Trimcinolone Acetonide 173 KB
605 Semaglutide IGlar SGT2i 160 KB
606 Rivaroxaban 148 KB
607 MEDI4736 aug 211 KB
608 MEDI4736 189 KB
609 Ceritinib 144 KB
610 INC280 2112 KB
611 Ticagrelor 158 KB
612 QMF149 225 KB
613 Indacaterol 277 KB
614 Insulin Aspart 195 KB
615 NW-3509A 153 KB
616 BIASP-30 198 KB
617 Insulin degludec may 216 KB
618 Lopinavir/Ritonavir 144 KB
619 MDR-TB Drugs 151 KB
620 B1695502 225 KB
621 Sofosbuvir 143 KB
622 RLX030 190 KB
623 Clindamycin 189 KB
624 Semaglutide 2016 256 KB
625 Masitinib 178 KB
626 Carbetocin RTS 1542 KB
627 YLB113 184 KB
628 Insulin degludec 245 KB
629 BYL719 189 KB
630 LEE011 183 KB
631 Nintedanib 204 KB
632 Pregabali 182 KB
633 Bevacizumab 181 KB
634 Pregabalin 182 KB
635 Recruitment Rule of Drugs Inspector in CDSCO 2,512kb
636 Alirocumab 191 KB
637 CT P10 186 KB
638 QGE031 CQGE031B2201 166 KB
639 QGE031 S.c 191 KB
640 FG-3019s 190 KB
641 Roxadustat Anemia 190 KB
642 Roxadustat 187 KB
643 GENA-05 160 KB
644 Subcutaneous Secukinumab 221 KB
645 Dydrogesterone 178 KB
646 Pregabalin as adjunctive 171 KB
647 Linaclotide 225 KB
648 LCZ696 NYHA 204 KB
649 LCZ696 Paradigm 235 KB
650 Moroctocog alfa 166 KB
651 RanibizumAB 173 KB
652 Steroids in Iga 181 KB
653 Canagloflozin 209 KB
654 Insulin Aspart BIAsp 201 KB
655 Salmeterol 193 KB
656 Masitinib Lymphoma 189 KB
657 LEE011 NSAI 182 KB
658 Guidance Document on Grant of Licenses in Form 11(Test License) 618kb
659 Checklist for Test License Appli8cations Effective From 15 June 2011 143kb
660 Amended Checklist for test License Applications Effective From 15 June2011 69kb
661 DE-109 180 KB
662 Octafibrin 170 KB
663 ACTG 5288 170 KB
664 Dabigatran etexilate dual 239 KB
665 Clindamycin 1% 215 KB
666 Bococizumab 369 KB
667 Bococizumab PF-04950615) 368 KB
668 LEE011 with Lerozole 184 KB
669 Masitinib 210 KB
670 Masitinib Folfiri 209 KB
671 Dabigatran 197 KB
672 Rituximab 190 KB
673 Chemotherapy 178 KB
674 Dabigatran Etexilate 255 KB
675 Fibrinogen 182 KB
676 2 PARALLEL Masitinib 213 KB
677 Chemoradiation 162 KB
678 Ticagelor 189 KB
679 QGE031 183 KB
680 Isoniazid 172 KB
681 Tiotropium 265 KB
682 Labetalol 162 KB
683 Nifedipine Daga 165 KB
684 Nifedipine Daga 165 KB
685 DS-5565 178 KB
686 Insulin Detemir 181 KB
687 NNC0195-0092 188 KB
688 LY2963019 200 KB
689 LCI699 173 KB
690 Mifepristone 160 KB
691 Mifepristone and Misoprotol 163 KB
692 Pasireotidestudy 171 KB
693 Pasireotide 173 KB
694 Policy Initiatives Planned for 2015 85kb
695 Octafibrin GCT/64/14 197 KB
696 Semaglutide 2014 198 KB
697 Antidepressant 149 KB
698 LY2605541 200 KB
699 Alglucosidase Alfa 164 KB
700 Dabigatran BI 655075 223 KB
701 Ranibizumab VEGF 180 KB
702 Ranibizumab CRVO 180 KB
703 Ranibizumab Brilliance 191 KB
704 Rituximab RTXM83 185 KB
705 Afatinib BiBW 2992 189 KB
706 Trastuzumab 216 KB
707 Afatinib for Patients 172 KB
708 Alglucosidase 171 KB
709 Herpes Zoster 169 KB
710 Pregabalin Adjunctive 188 KB
711 Paclitaxel 178 KB
712 Eravacycline 197 KB
713 UT-15C 176 KB
714 Dapagliflozin 10mg 201 KB
715 UT-15C Phase III 189 KB
716 Bevacizumab AVASTIN 178 KB
717 LDK378 219 KB
718 Pasireotide LAR 163 KB
719 Pertuzumab 180 KB
720 Ifetroban Injection 192 KB
721 FactorVIII 122 KB
722 Baricitinib in Patients 222 KB
723 Adalimumab 179 KB
724 Cyclosporine 190 KB
725 Fluocinolone acetonide intravitreal 174 KB
726 Ranibizumab 0.5 mg 188 KB
727 Everolimus with reduced calcineurin 256 KB
728 Fosaprepitant 191 KB
729 Masitinib 198 KB
730 Liraglutide Sitagliptin 181 KB
731 Sitagliptin 213 KB
732 NOVA22007 191 KB
733 QAW039 on FEV1 184 KB
734 Clindamycin benzoyal peroxide 265 KB
735 BCD-020 223 KB
736 Pasireotide S.C 173 KB
737 Ciprodex 212 KB
738 Enbrel 194 KB
739 Ceftazidime CAZ AVI 200 KB
740 Exenatide 174 KB
741 Daclizumab 186 KB
742 Remicade 215 KB
743 BCD-021 214 KB
744 Buparlisib 182 KB
745 Insulin Degludec versus insulin glargine 277 KB
746 Liraglutide versus sulphonylurea 211 KB
747 BCD-022 217 KB
748 tolerability of Secukinumab 176 KB
749 Everolimus RADOO1 192 KB
750 Everolimus alone 183 KB
751 Transfer Policy 421kb
752 SAR236553 681 KB
753 Afatinib 225 KB
754 subcutaneous Secukinumab 166 KB
755 Sofosbuvir plus ribavirin 291 KB
756 Everolimus 243 KB
757 Ceftazidime 283 KB
758 Fluocinolone 292 KB
759 FLU D-QIV 278 KB
760 FIAsP Insulin 280 KB
761 FIAsP 2014 279 KB
762 Tenofovir Disoproxil 303 KB
763 Tenofovir Alafenamide TAF 314 KB
764 olasertib 289 KB
765 Diclofenac Gel 370 KB
766 Baricitinib 357 KB
767 Baricitinib LY3009104 348 KB
768 BEZ235 846 KB
769 TechnologyMG145 1410 KB
770 LAF237 293 KB
771 Producttrastuzumab 926 KB
772 Liraglutide sc Injection 306 KB
773 Human rh FV III 301 KB
774 Fesoterodine 305 KB
775 Tenofovir 342 KB
776 Octefibrin 290 KB
777 Lixisenatid Subcutaneous 382 KB
778 CP-690,550 296 KB
779 ART-123 303 KB
780 Quotation of rate contract for supply of Photostat Paper (JK Brand) Last date (27 Jul 2012 ) 129kb
781 Re-tendering for Housekeeping and General cleanliness in the CDSCO(HQ), FDA Bhawan, Kotla Road, New Delhi Last Date ( 27 Jul 2012 ) 903kb
782 Extension of Date of Notice Inviting Tender (NIT) Last Date( 27 Jul 2012 ) 370kb
783 Annual Rate Contract for Hiring taxies 1 Last Date( 27 Jul 2012 ) 132kb
784 Annual Rate Contract for Hiring taxies 2 Last Date ( 27 Jul 2012 ) 1,775kb
785 Annual Rate Contract for Hiring taxies 3 Last Date( 27 Jul 2012 ) 162kb