DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)99. NOSCAPINE99.1 The following contraindication shall be included on the labels ofproducts containing Noscapine:Contraindicated in Women of Child-bearing Potential99.2 The following statement shall be included in the package inserts ofproducts containing Noscapine:WARNINGExperimental data now suggests that noscapine may exhibit a mutageniceffect in vitro. Because of the possible consequent risk to the developingfoetus, the products containing noscapine is contraindicated in women ofchild bearing potential, therefore pregnancy should be excluded beforetreatment, and effective contraception maintained throughout treatmentwith such products.PRECAUTIONIn view of potential mutagenicity shown in vitro, potential risks should bebalanced against anticipated benefits when treating children andneonates.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 402
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)100. NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)The following statement shall be included in the package insert of productscontaining NSAID including COX-2 Inhibitors:WARNINGRisk of GI Ulceration, Bleeding and Perforation with NSAIDSerious GI toxicity such as bleeding, ulceration and perforation can occur atany time, with or without warning symptoms, in patients treated with NSAIDtherapy. Although minor upper GI problems (e.g. dyspepsia) are common,usually developing early in therapy, prescribers should remain alert forulceration and bleeding in patients treated with NSAIDs even in the absence ofprevious GI tract symptoms.Studies to date have not identified any subset of patients not at risk ofdeveloping peptic ulceration and bleeding. Patients with prior history of seriousGI events and other risk factors associated with peptic ulcer disease (e.g.alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderlyor debilitated patients seem to tolerate ulceration or bleeding less than otherindividuals and account for most spontaneous reports for fatal GI events.101. OLANZAPINEPlease refer to ANTIPSYCHOTIC AGENT102. PARACETAMOLThe following statement shall be included on the labels and in the packageinserts of products containing Paracetamol:WARNINGThis preparation contains PARACETAMOL.Do not take any other paracetamol containing medicines at the same time.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 403
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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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