An overveiw on regulation of otc drug product in different country
PRESENTED BYROSHNI RATHORE
DEFINITIONOTC Drugs are drugs that have been found to be safe andappropriate for use without the supervision of a health careprofessional such as a physician, and they can be purchased byconsumers without a prescription. Self treat Self-diagnose Self manage Advertised.
At present, there is no OTC schedule in the Drugs andCosmetics Rules 1945.Hence, any drug outside schedule H, G and X is considered tobe an OTC drug.1. SCHEDULE KHousehold remediesItem No.13Form 20 AForm 20B
Examples Aspirin tablets, Antacid preparation, Analgesic balm etc. Cold and nasal congestion preparations &syrups, lozenges, pills and tablets for cough. Digene (antacid) Paracetamol
2. Exemption of Schedules G, H or X Topical or external use (except ophthalmic and ear / nosepreparations containing antibiotics and / or steroids)applications of the ingredients from these schedule. Clause – 2 : The salts, esters, derivatives and preparationscontaining the above substances excluding those intended fortopical or external use.
Examples Diclofenac (Volini Gel). Clotrimazole. Oxymetazoline. Chericof and Honitus(Chlorpheniramine).
3. AYURVEDIC OTC DRUGSThe Ayurvedic State Licensing Authorities.Examples Vicks VapoRub, Amrutanjan Pain Balm, Zandu Pain Balm, Iodex Pain Balm, Moov Pain Cream, Itch Guard Cream, Eno Fruit Salt antacid
1. The Drugs and Cosmetics Act, 1940 (DCA) and itssubordinate legislation, the Drugs and Cosmetics Rules, 1945(DCR).2. Other regulations are which have a bearing on thepharmaceutical business in India;Drug (Prices Control) Order, 1995,Example; Acetylsalicylic acid And EphedrineDrugs (Magic Remedies) Objectionable AdvertisementAct, 1954
1.Rule 96 of the DCR2. Rule 973. Maximum Retail Price (MRP) printed on the label.The Standards of Weights & Measures Act(Packaged Commodities)4.Warnings5. Symbols (Rx, X )6. Rule 161
Non Prescription(OTC) RegistrationSingle or combination containing non-prescription drugs, i.e. outof Schedule G,H or X cannot be directly granted as OTC.First it will be approved as Rx (prescription) and later onapplication is required to be filed for switch from Rx to OTC.
In the United States the manufacturing & sale OTC drug productis regulated by, USFDAOTC Drug Product Allowed to be marketed either:(1) Pursuant to an FDA OTC monograph; or(2) Pursuant to an NDA for products that do not fit within aspecific monograph
Types of NDAs1. Rx to OTC switches Full switch (NDA supplement). Partial switch (new NDA).2. Direct to OTC NDA deviation ( NDA deviation (330.11)) Generic (ANDA)
Division of Non-prescription regulationDevelopment(DNRD) in ODE IV. “Recipe book” for marketing an OTC drug „ „ A list and explanation of GRASE conditionsGRASE = Generally Recognized As Safe and Effective „ „ Final monographs are published in Code of FederalRegulations: 21 CFR parts 331-358
§331.10 Activeingredients…Calcium, as carbonateor phosphate; maximum dailydosage limit 160mEq. calcium(e.g., 8 grams calcium carbonate331.30(b) Indications…‘‘For therelief of’’ (optional, any or all ofthe following:) ‘‘heartburn,’’ ‘‘sourstomach, and/or ‘‘acidindigestion’’331.30(c) Warnings…“Do not takemore than (max. rec. daily dosage)in a 24-hour period, or use themaximum dosage of this productfor more than 2 weeks
Restricted OTC SubstancesExamples;1. Methamphetamine The Methamphetamine Precursor Control Act A House Bill 512 passed in the State Senate onFebruary 2,20102. Preventing Abuse Of cough treatment Act (PACT Act) Dextromethorphan3. Emergency Contraceptive
1. 21 CFR 201.66 for labelling requirement of OTC product inUS.2. Drug FactsStandardized labelling format Similar to “Nutrition Facts”& “Supplement Facts”3. Federal Trade Commission (FTC)4. National Advertisement Division
Tylenol Tetrahydrazoline Next choice Plan B
The main directives regarding medical products for human useare as follows: 2001/83/ECArticles 70-75 of Directive 2001/83/EC have been reservedfor classification of medical products for human use.Article 70 stated that when a marketing authorization isgranted, the competent authorities should specify theclassification of the medical product as one subject to medicalprescription, or as one not subject to medical prescription.
1. Article 71 State that; Criteria to be use for classification ofmedicinal product, Established With purpose to prioritizepatient safety.Prescription drugs Subjected to be Danger Used incorrectly Side effect Administered parenterally2. Article 72
1. DIRECT PROMOTION TO CONSUMERSArticle 88 of the Directive 2001/83/EC dated November 6, 20012. OTC LABELLING REQUIREMENTArticles 54-69 of the directive 2001/83/EC are reserved forthe labelling and prospectuses of medical products for humanuse.
Article 54,55,59 of Directive 2001/83/EC Article 62 of Directive 2001/83/EC Title V of the Directive 2001/83/ECArticles listing the requirements relating to the contents of thelabelling and package.
S.NOKey point consideration US FDA INDIA EUROPE1. OTC NDAAPPLICATION Us FDA Drug & cosmetic act1940 (Forprescription drugs)2001/83/EC2. OTC MONOGRAPH The Division of Non-prescription RegulationDevelopment (DNRDNA NA3. LABELLINGREQUIREMENT 21CFR 201.66NO SeparaterequirementArticles 54-69 ofthe directive2001/83/EC4. ADVERTIZMENT Federal Trade Commission(FTC)Magic remedies act1954Article 88 of theDirective2001/83/EC5. DISTRIBUTION Supermarket Generaly smallindependent shopSupermarket/ even atfuel station6. SWITC RX TO OTC Drug review panel Lacks such system Directive2004/27/EC7. PRICE CONTROL NA DPCO 1995 89/105/EEC(TRANPERENCYDIRECTIVE)
UNITED STATEThe manufacturer requests the switch by submitting asupplemental application to its approved NDA.• A petition from the manufacturer to the FDA.• Recommendation from the OTC review panelEUROPEArticle 74a of Directive 2001/83/EC amended by 2004/27/EC• significant preclinical trails and clinical trial• Data exclusivity
Regulation requirement• Reduce drug abuse• Improve patient safetyComparatively studyIndia is one of emerging country require separate criteria for“OTC REGULATION” for enhance patient safety and reduceDrug abuse.ORGANISATION OF PHARMACEUTICAL PRODUCERS(OPPI) works toward the promotion of OTC in INDIA.