DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

Drug Registration Guidance Document (<strong>DRGD</strong>)No. Subject Matter Example(s) Notes4. Clinical Trial results or anyinformation on clinical trial done onproductExample:“Clinically Tested”“Randomized Double BlindPlacebo Control Clinical Study”Such statements are prohibited onlabels, as per Medicines (Advertisementand Sale) Act 1956 requirement5. Photograph of product pioneer Not allowed6. Reference to Hadith/ Al-Quran/Bible/Prohibited on product labelReligious books7. Opinion of prominent figure(s) onproduct or its active ingredient/content8. Label design (graphic and color)similar to labels from anothercompanyExample:Opinion of product/formulation inventorProhibited on product labelProhibited on product label9. Statement on herbal origin Example:Source from theMountains of AlpsAllowed if proven trueNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 298
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Subject Matter Example(s) Notes10. Introduction of founder/manufacturer11. Logo with certification Example:SIRIM/ ISO / GMP /HACCPProhibited on product labelProhibited on product label becausecertification renewal is on a yearly basis12. Name/ Statement / Logo/ registeredtrademark which does not satisfythe specifications of the TraditionalUnit13. Patency claim/ Patency number/Special technique used/ superiorityin ingredients(Example: capsule coat)14. Nutritional claims with analysiscertificate attached15. Graphics or picture of internalorgansExample:“Dr.ABC‟s Formula”“Nothing like it”Example:Patented techniqueExample:Calorie, Fat, Protein andothersExample:Kidney, Heart, Nerves.Prohibited on product labelAllowed if proven trueProhibited on product labelThis is not a food supplement.Prohibited on product label16. Photograph of celebrities Example: Prohibited on product labelNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 299
Page 1 and 2:
Drug Registration Guidance Document
Page 3 and 4:
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19:
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Page 164 and 165:
Page 166 and 167:
Page 168 and 169:
Page 170 and 171:
Page 172 and 173:
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
Page 222 and 223:
Page 224 and 225:
Page 226 and 227:
Page 228 and 229:
Page 230 and 231:
PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233:
- All information must be provided
Page 234 and 235:
Page 236 and 237:
Page 238 and 239:
Page 240 and 241:
Page 242 and 243:
1.2 EXEMPTION FROM PRODUCT REGISTRA
Page 244 and 245:
Page 246 and 247:
Page 248 and 249: Drug Registration Guidance Document
Page 292 and 293: For product containing Red Yeast Ri
Page 348 and 349:
Page 350 and 351:
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366 and 367:
Page 368 and 369:
Page 370 and 371:
Page 372 and 373:
Page 374 and 375:
Page 376 and 377:
Page 378 and 379:
Page 380 and 381:
Page 382 and 383:
Page 384 and 385:
Page 386 and 387:
Page 388 and 389:
Page 390 and 391:
Page 392 and 393:
Page 394 and 395:
Page 396 and 397:
Page 398 and 399:
Page 400 and 401:
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438 and 439:
Page 440 and 441:
Page 442 and 443:
Page 444 and 445:
Page 446 and 447:
Page 448 and 449:
Page 450 and 451:
Page 452 and 453:
Page 454 and 455:
Page 456 and 457:
Page 458 and 459:
Page 460 and 461:
Page 462 and 463:
Page 464 and 465:
Page 466 and 467:
Page 468 and 469:
Page 470 and 471:
Page 472 and 473:
Page 474 and 475:
Page 476 and 477:
Page 478 and 479:
Page 480 and 481:
Page 482 and 483:
Page 484 and 485:
Page 486 and 487:
Page 488 and 489:
Page 490 and 491:
Page 492 and 493:
Page 494 and 495:
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?