DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SUBSTANCES122. ROSIGLITAZONE123. ROYAL JELLY124. SALBUTAMOL125. SEDATIVE – HYPNOTIC PRODUCTS126. SELENIUM SULPHIDE127. SENNA LEAF (CASSIA) AND RHUBARB/ RADIX et RHIZOMA RHEI128. SODIUM METABISULPHITE (EXCIPIENT)129. SODIUM VALPROATE130. ST. JOHN‟S WORT (Hypericum perforatum)131. STATINS132. SULPHONAMIDES/ TRIMETHOPRIM133. TERBUTALINE134. TETRACYCLINE SYRUP135. THIOMERSAL136. THROMBOLYTIC AGENTS137. TIAPROFENIC ACID138. TRETINOIN (TOPICAL)139. TRIAZOLAM140. TRIPROLIDINE141. VARENICLINE142. VITAMIN K143. WARFARIN144. ZIPRASIDONE145. ZOLPIDEM TARTRATE146. ZOPICLONENational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 358
Drug Registration Guidance Document (<strong>DRGD</strong>)Table 3: Details of Specific Labelling RequirementsNO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)1. 5-ALPHA REDUCTASE INHIBITOR (5-ARI)The following statement shall be included in the package inserts of productscontaining 5-ARI:1.1 PRODUCT CONTAINING FINASTERIDE 5MGWARNINGS AND PRECAUTIONSIncreased Risk of High-Grade Prostate CancerMen aged 55 and over with a normal digital rectal examination and PSA≤3.0 ng/mL at baseline taking finasteride 5 mg/day in the 7-year ProstateCancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). Similar resultswere observed in a 4-year placebo-controlled clinical trial with another 5-alpha reductase inhibitor (dutasteride, AVODART) (1% dutasteride vs0.5% placebo).5-alpha reductase inhibitors may increase the risk of development of highgradeprostate cancer. Whether the effect of 5-alpha reductase inhibitorsto reduce prostate volume, or study-related factors, impacted the results ofthese studies has not been established.Increased Risk of Breast CancerBreast cancer has been reported in men taking finasteride 5 mg during thepost-marketing period. Physicians should instruct their patients to promptlyreport any changes in their breast tissue such as lumps, pain,gynaecomastia or nipple discharge.ADVERSE EVENTS: POST MARKETING EXPERIENCEMale breast cancer1.2 PRODUCT CONTAINING FINASTERIDE 1MGWARNINGS AND PRECAUTIONSIncreased Risk of High-Grade Prostate CancerMen aged 55 and over with a normal digital rectal examination and PSA≤3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of[Brand Name]) in the 7-year Prostate Cancer Prevention Trial (PCPT) hadan increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8%vs placebo 1.1%). Similar results were observed in a 4-year placebocontrolledclinical trial with another 5-alpha reductase inhibitorNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 359
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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