Counter par teen cheezein roz nibhani padti hain: dawa registered pharmacist ki personal supervision mein hi bike (Rule 65(2)), expiry ke baad dawa shelf par na rahe (Rule 65(17)), aur licence ki retention fee har paanch saal khatam hone se pehle jama ho jaye. 2017 ke baad drug licence expire nahi hota, lekin fee chooki to deemed cancelled.
Medical store chalane ke liye kaun-kaun se licence aur registration hamesha valid hone chahiye?
Retail drug licence ab har paanch saal renew nahi karana padta. 27 October 2017 ki notification G.S.R. 1337(E) ne Rule 63 badal diya, aur tab se Form 20, 20A, 20B, 20BB, 20F, 20G, 21, 21A, 21B aur 21BB wale sale licence hamesha ke liye valid rehte hain, bas har aane wale paanch saal poore hone se pehle licence retention fee jama honi chahiye (Drugs Rules 1945, CDSCO consolidation 01-07-2024).
Retention fee utni hi hoti hai jitni licence lete waqt lagi thi. Der hui to har mahine licence fee ka 2% judta jata hai, zyada se zyada chhah mahine tak. Uske baad licence deemed cancelled maan liya jata hai, aur cancelled licence par bikri ka matlab hai bina licence bikri: Drugs and Cosmetics Act 1940 ki Section 27(b)(ii) mein 3 se 5 saal ki qaid aur kam se kam ₹1 lakh ya zabt dawaon ki teen guna keemat, jo zyada ho, ka jurmana. Aaj ki sabse mehngi laparwahi yahi hai, kyunki calendar par tareekh koi yaad nahi dilata.
Nayi dukaan ka application Form 19 mein jata hai aur 2026 mein uski fee ₹1,500 hai; restricted licence (Form 19A) aur Schedule X licence (Form 19C) ke liye ₹500 (Rule 59(2)). Application state government ke appoint kiye hue licensing authority yaani state drugs control administration ya state FDA ke paas jata hai, CDSCO ke paas nahi (Rule 59(1)). Rajya apne portal par inspection aur processing charges alag se jodte hain, isliye jeb se nikalne wali total rakam rajya ke hisaab se badalti hai. Apne state ki fee page khud ek baar dekh lijiye.
Form 20 mein hi likha hai ki licence ki compliance jaanch risk-based tareeke se kam se kam har teen saal mein ek baar hoti hai. Yaani inspection ki tareekh aapke haath mein nahi hai; register roz update rakhna hi ekmatra taiyari hai. Licence aur pharmacist ka registration certificate counter ke paas laga rahe to inspection ke din aadha kaam waise hi ho jata hai.
Baaki registration dawa kanoon ke nahi, aam kaarobar ke hain: GST registration, nagar nigam ka trade licence aur rajya ka shops & establishment registration. Inki fee aur turnover limits har rajya mein alag hain, isliye numbers apne CA ya nagar nigam se confirm kijiye. MSME wala Udyam registration faydemand hai par drug licence ki shart nahi.
Counter par registered pharmacist ki maujoodgi ko lekar niyam kya kehte hain?
Rule 65(2) saaf hai: prescription wali har bikri registered pharmacist ke haathon ya uski personal supervision mein honi chahiye, aur us din uska State Pharmacy Council registration current hona chahiye. Uske upar Rule 64(1) kehta hai ki premises kisi competent person ke zimme ho aur Schedule N ki sharton par khara utre.
Pharmacy Act 1948 ke tehat registration ke liye maanya qualification D.Pharm (do saal), B.Pharm aur Pharm.D hain. M.Pharm postgraduate degree hai, registration ka alag raasta nahi. Yaad rakhiye ki inspector degree ka certificate nahi, council ka registration dekhta hai. Degree hona alag baat hai, registration current hona alag.
Agar maalik ke paas khud pharmacy ki degree nahi hai to raasta ek hi hai, full-time registered pharmacist rakhna. Kisi doosre ke certificate par dukaan chalana pehle bhi gairkanooni tha aur ab pakde jaana kaafi aasan ho gaya hai: PCI ne 13 December 2023 se pharmacist registration ki Aadhaar authentication anivarya kar di hai, to ek hi aadmi do dukaanon ke kaagzon mein nahi dikhaya ja sakta. Matriculation plus chaar saal ke anubhav wala competent person ka raasta wholesale licence ke liye hai (Rule 64(2)), retail pharmacy ke liye nahi.
Inspection mein teen cheezein maangi jati hain, wahi taiyar rakhiye: pharmacist ka registration certificate uski renewal date ke saath, appointment letter ya affidavit, aur yeh ki counter par wo sach mein baitha rehta hai. Pharmacist ki gairhaazri mein bikri Rule 65(2) ka ullanghan hai; Rule 66 ke tehat licensing authority show-cause ke baad licence suspend ya cancel kar sakti hai, aur Section 27(d) mein 1 se 2 saal ki qaid aur kam se kam ₹20,000 jurmana banta hai.
Prescription aur Schedule H, H1, X dawaon par kya karein aur kya bilkul na karein?
Indian dawa kanoon mein "OTC" naam ki koi official category hai hi nahi. Sahi bantwara scheduled aur non-scheduled ka hai: Schedule H, Schedule H1 aur Schedule X ki dawaein sirf registered medical practitioner ke prescription par bik sakti hain (Rule 65(9)), aur baaki dawaein bina parche ke bik sakti hain lekin tab bhi registered pharmacist ki nigrani mein.
Schedule H1 ki list ab 50 molecules ki hai. Oxytocin (47), Tapentadol (48), Oseltamivir (49) aur Zanamivir (50) baad mein jode gaye, aur do antiviral judne ka matlab hai ki har flu season mein yeh register khulega. H1 wali dawa bechte waqt alag register mein prescriber ka naam aur pata, mareez ka naam, dawa ka naam aur quantity likhna zaroori hai; yeh register teen saal rakhna hai aur inspection mein dikhana hai (Rule 65(3)(h)).
Schedule X ka mamla iske bhi upar hai. Uske liye alag licence lagta hai (Form 19C ke application par Form 20F/21G), stock lock aur key mein alag rehta hai, aur uske prescriptions tatha signed orders do saal sambhal kar rakhne hote hain. Bikri ke cash ya credit memo ki copy teen saal, aur baaki sabhi register aakhri entry se kam se kam do saal.
Ab do "bilkul na karein". Parcha padha na ja raha ho to andaze se dawa mat dijiye; grahak ko wapas doctor ke paas bhejna hi safe hai, kyunki galat molecule nikal jaye to jawabdehi counter par aati hai. Aur H1 ki dawa "regular customer hai, parcha kal le aayega" keh kar mat dijiye. Register mein khali column inspector ke liye sabse aasan finding hai.
Dawaon ki storage aur cold chain kaise sambhalein?
Kisi central niyam mein "AC lagana zaroori hai" nahi likha. Rule 64(1) itna kehta hai ki premises paryapt ho aur usme dawaon ke gun bachaye rakhne layak proper storage accommodation ho. Yaani legal test wahi hai jo pack ke label par chhapa hai: label kehta hai "store below 25°C", to shelf par wahi haalat honi chahiye. Isliye AC ya exhaust, jo bhi us kamre ke liye kaam kare, us shart ko poora karne ka zariya hai, apne aap mein niyam nahi.
Fridge tabhi zaroori hai jab aap cold-chain lines rakhte hain: vaccines, insulin, kuch eye drops. Jahan fridge hai wahan thermometer aur roz ka temperature log inspection mein sabse achha sabooth banta hai, aur bijli jaane par nuksan ka andaza bhi wahi deta hai. Lambi power cut wale ilake mein fridge ko inverter ya generator line par rakhna aur bina zaroorat ke gate na kholna, do sabse sasti aadatein hain. Barish aur garmi ke mahinon mein cardboard cartons deewar se sata kar zameen par rakhne ki aadat chhod dijiye; namak wali hawa aur seelan strip ki packaging pehle kharab karti hai.
Expired aur damaged maal saleable shelf se poori tarah alag rehna chahiye. Rule 65(17) sirf itni chhoot deta hai ki manufacturer ko wapas bhejne, reimbursement ya disposal tak aisa maal trade stock se alag rakha ja sakta hai, cartons mein, jinke upar saaf-saaf "Not for sale" likha ho. Schedule N ki premises sharten bhi yahin lagoo hoti hain: dispensing area kam se kam 6 square metre, chhat 2.5 metre se neeche nahi, dhone layak farsh, aur POISON likhi almari taale mein.
Expiry aur near-expiry stock ka sahi tareeka kya hai?
Rule 65(17) do kaam mana karta hai, bechna aur stock rakhna, dono. Iska practical matlab yeh hai ki inspector ko bikri sabit karne ki zaroorat hi nahi; saleable shelf par expired strip mil jana apne aap mein ullanghan hai, aur wo Section 27(d) mein aata hai.
Isliye near-expiry ka audit mahine ki fixed tareekh par hona chahiye, jaise har mahine ki 1 tareekh, aur uska koi shortcut nahi hai: rack-by-rack batch aur expiry padhna. Distributor kitne mahine pehle wapas leta hai, yeh har distributor ki apni policy hai aur aapke agreement mein likhi hoti hai; usi window se ulta gin kar apni internal date tay kijiye. Wapasi ke waqt credit note, return challan aur usse judi purchase bill ki copy ek jagah rakhiye, warna mahine baad ledger mein sirf ghata dikhta hai aur uska koi kaagaz nahi.
Batch number ki lai kabhi mat todiye. Rule 65(3) purchase record mein tareekh, supplier ka naam, pata aur licence number, dawa ka naam, quantity, batch aur manufacturer maangta hai, aur purchase bills serially numbered tatha chronological order mein rakhne hote hain. Recall ki khabar aane par yahi record batata hai ki wo batch aapke paas kitna aaya aur kahan gaya. Bikri ke memo par bhi batch chhap raha ho to jaanch minton ka kaam ban jati hai.
Price, bill aur GST mein medical store wale kahan phanste hain?
MRP se ek rupaya upar bhi nahi. DPCO 2013 ka para 26 kehta hai ki grahak se current price list ya label par chhape daam, jo kam ho, usse upar nahi liya ja sakta; para 27 ke tehat strip kaat kar di gayi dawa ka daam pro-rata se zyada nahi ho sakta; aur para 25(3) har retailer par manufacturer ki price list tatha supplementary price list wahan lagane ki zimmedari daalta hai jahan grahak use dekh sake. Ceiling price ki jaanch NPPA ki Pharma Sahi Daam service par ho jati hai, aur NPPA ceiling tatha revised retail prices lagatar notify karta rehta hai (taza notifications 27 August aur 1 September 2026).
2026 mein ek naya jokhim juda hai. 30 June 2026 ko notified Drugs (Prices Control) Amendment Order 2026 (S.O. 3516(E)) ne para 24(1) mein proviso joda hai: agar manufacturer sabooth de de ki usne ghati hui price list do hafton ke andar dealers tak bheji, do national akhbaron mein us kami ka vigyapan diya aur apni website par daali, to overcharged rakam sirf us stock par nikali jayegi jo ceiling price se upar bechte hue pakde gaye retailer, distributor ya stockist ke paas tha. Seedha matlab: price cut ke baad purani MRP wala maal bechte rehna ab dukaan ki apni deni hai.
GST ka rate bhi badal chuka hai. 56th GST Council ki 3 September 2025 ki baithak ke baad, 22 September 2025 se sabhi drugs aur medicines par GST 12% se ghat kar 5% ho gaya; 33 lifesaving dawaein 12% se nil par aayin aur 3 aur 5% se nil par; kai medical devices tatha diagnostic kits 18% ya 12% se 5% par aa gaye. Billing software ka rate, purane stock par MRP sticker ka sawal aur "bhaiya, ab sasta kyun hai" wala grahak ka sawal, teenon isi tareekh se jude hain.
Bill par kanjoosi mat kijiye. Har bikri ka cash ya credit memo baniye aur uski copy teen saal rakhiye, GST registered hain to GSTIN aur sahi 5% rate bill par dikhe, aur batch number bill par chhapwa lijiye. Bina bill ki nakad bikri record ki us kadi ko todti hai jo kanoon aapse maangta hai, aur shikayat ya recall ke waqt aapke paas apna bachav hi nahi bachta. Format ki bareekiyan GST invoice ke rules mein dekh lijiye.
Online pharmacy ke discount dekh kar daam girane se pehle hisaab lagaiye. DPCO scheduled formulations ki ceiling price mein retailer ka margin 16% pehle se tay kar chuka hai, isliye neeche jaane ki gunjaish utni hai hi nahi jitni vigyapan dikhate hain.
Kaun si galtiyan drug licence suspend ya cancel kara sakti hain?
Bina valid licence dawa bechna sabse bhaari apradh hai: Section 27(b)(ii) mein 3 se 5 saal ki qaid aur kam se kam ₹1 lakh ya zabt dawaon ki teen guna keemat, jo zyada ho, ka jurmana. Baaki zyadatar chooken Section 27(d) mein aati hain, jahan 1 se 2 saal aur kam se kam ₹20,000 ka pravdhan hai. Nakli ya adulterated dawa se kisi ki maut ya gambhir nuksan ho jaye to Section 27(a) mein kam se kam 10 saal se lekar aajeevan kaid aur kam se kam ₹10 lakh jurmana hai.
| Galti | Inspector ko kya dikhta hai | Nateeja |
|---|---|---|
| Pharmacist maujood nahi ya registration lapsed | attendance, appointment letter, PCI registration ki date | Rule 65(2) bhang; Rule 66 mein show-cause ke baad suspension ya cancellation; s.27(d) |
| Schedule H1 register adhoora ya gayab | khali column, teen saal ka record na hona | s.27(d): 1 se 2 saal, kam se kam ₹20,000 |
| Expired dawa bikne wale shelf par | batch aur expiry ki jaanch | Rule 65(17) bhang; bikri sabit karne ki zaroorat nahi |
| Bina licensed source se kharid | memo par supplier ka licence number nahi, bills kram mein nahi | Form 20 ki shart 4 aur Rule 65(3) bhang |
| Retention fee paanch saal mein jama nahi | licensing authority ka record | har mahine 2% extra, chhah mahine baad licence deemed cancelled |
| MRP ya ceiling price se upar bikri | bill banaam price list, grahak ki shikayat | DPCO ke tehat overcharged rakam ki vasooli, 2026 sanshodhan ke baad dukaan par |
| Nakli ya bina label wala stock | pack par batch, expiry, manufacturer ka licence number | s.27(a) tak ja sakta hai |
Kharid hamesha licensed source se ho. Form 20 ki shart 4 kehti hai ki koi dawa tab tak nahi bechi jayegi jab tak wo kisi valid licence wale dealer ya manufacturer se cash ya credit memo par na khareedi gayi ho. B2B online distributor se mangwana galat nahi hai, bas bechne wale ke paas wholesale licence ho aur memo par uska licence number chhapa ho.
Nakli maal pakadne ka ek naya auzaar bhi mil gaya hai. Rule 96(6) aur (7) tatha Schedule H2 ke tehat 300 named brand packs par manufacturer ko bar code ya QR code lagana hai, jisme unique product identification code, generic aur brand naam, manufacturer, batch number, manufacturing tatha expiry date aur manufacturing licence number hota hai. Consignment utarte waqt in me se kuch pack scan kar lena ek minute ka kaam hai aur poore godown ka bharosa badha deta hai.
Inspection notice ya show-cause aaye to sabse buri pratikriya chup reh jana hai. Rule 66 ke tehat licence radd karne se pehle aapko suna jana zaroori hai, isliye di gayi tareekh ke andar likhit jawab dijiye, purchase bills, register aur pharmacist ke kaagaz ki copy lagaiye, aur jo kami sach mein hai use theek karke uska sabooth bhi saath bhejiye.
Stock, udhaar aur cash-flow ka hisaab kaise rakhein?
Munafa tay daayre mein bandha hai, khula nahi. DPCO 2013 scheduled yaani NLEM 2022 wali formulations ki ceiling price mein retailer ke liye 16% margin pehle se jod kar rakhta hai; non-scheduled dawaein sirf monitor hoti hain, jahan MRP baarah mahine mein 10% se zyada nahi badh sakti. Branded, generic aur non-scheduled lines ke margin ka koi bharosemand sarkari aankda maujood nahi hai, isliye kisi lekh ke average par mat chaliye; apni purchase bill aur bikri se khud nikaliye ki kis line par kitna bachta hai.
Asli risav dead stock mein hota hai. Jo dawa teen mahine mein ek baar bikti hai wo shelf par paisa nahi, expiry ki tareekh jod rahi hai. Mahine mein ek baar fast mover aur slow mover ki list alag kijiye, slow walon ka order chhota kijiye, aur near-expiry maal pehle nikaliye. Batch-expiry alert wala billing software yeh kaam minton ka bana deta hai; billing aur payment ke options POS machine kya hai aur uske prakar mein samajh aa jayenge.
Doosra dabav udhaar ka hai. Distributor aapko gine-chune din ki credit deta hai, jabki mohalle ke purane mareez aur aas-paas ke clinic mahine bhar ka khata chalate hain. Yahi antar working capital kha jata hai, khaas kar tab jab chadha hua udhaar copy mein likha ho aur kisi ko yaad na rahe. Udhaar ka hisaab rakhne ke liye OkCredit jaisa free digital khata app istemal kar sakte hain; har entry ka SMS grahak ko bhi chala jata hai aur payment reminder apne aap jate hain.
Online pharmacy aur Jan Aushadhi Kendra ke daur mein dukaan kaise tikayein?
E-pharmacy ke liye 2026 tak Drugs Rules mein koi notified niyam nahi hai. May 2026 mein yeh takrav khul kar saamne aaya: AIOCD ne 20 May 2026 ko deshvyapi 24 ghante ki pharmacy bandi bulai, 12 rajyon ke pharmacy sangathanon ne usme shaamil hone se inkaar kar diya, aur CDSCO ne kaha ki uthaye gaye mudde sakriya sameeksha mein hain aur is sector ka regulatory framework dekha ja raha hai (DD News, 18 May 2026).
Doosra dabav generic ka hai. 30 June 2026 tak 20,149 Jan Aushadhi Kendra chaalu ho chuke the, 784 mein se 776 zilon mein, aur sarkar ka lakshya March 2027 tak 25,000 ka hai (DD News, July 2026). Inki basket mein 2,110 dawaein aur 315 surgical, consumable tatha device items hain, jo branded vikalpon se 50 se 80% saste bikte hain. Kendra chalane walon ko mahine ki kharid ka 10% incentive milta hai, jo ₹10,000 prati maah tak seemit hai, aur 200 high-demand dawaein rakhne par ₹10,000 tak alag se (DD News, 20 March 2026).
Is muqable mein dukaan wahi bachati hai jo app nahi kar sakta. Ek ghante mein mohalle mein delivery, BP, sugar aur thyroid jaise chronic mareezon ko refill ki yaad dilana, aas-paas ke doctoron se bharose ka rishta, aur yeh ki parcha haath mein le kar koi insaan samjhaye ki dawa kab aur kaise leni hai. Sthaniya pehchaan banane ke tareeke apne business ki marketing kaise karein mein vistar se hain.
Nayi line jodne se pehle licence dekh lijiye. Schedule X wali dawaon ke liye alag licence chahiye (Form 19C, Form 20F/21G), aur jo cheez aapke licence mein darj nahi hai use rakhne se pehle state drugs control se poochh lena sasta padta hai.
Aage kya aa raha hai, wo bhi jaan lijiye. The Daily Brief (Zerodha) ki 14 August 2026 ki report ke mutabik Health Ministry ne Drugs and Cosmetics Act 1940 ki jagah lene ke liye ek draft Drugs, Medical Devices and Cosmetics Bill 2026 circulate kiya hai, jisme manufacturing licensing ko 36 rajya niyamakon se hata kar ek central authority ko dene, chhoti procedural chookon par mukadme ki jagah aarthik jurmana rakhne, aur pehli baar dawaon ki online bikri ko saaf taur par sambodhit karne ki baat hai. August 2026 tak yeh sirf draft hai aur stakeholder consultation mein hai, kanoon nahi; aaj ki duty wahi hai jo upar likhi hai.
Nayi dukaan khol rahe hain to kam-se-kam kya chahiye?
Kam se kam teen cheezein: retail licence ke liye 10 square metre ki jagah (usi premises par wholesale licence bhi lena hai to 15 square metre), Form 19 ke saath ₹1,500 ki fee, aur ek full-time registered pharmacist. Schedule N ke hisaab se dispensing area ek pharmacist par 6 square metre se kam na ho aur har extra pharmacist par 2 square metre aur juden, chhat 2.5 metre se neeche na ho, farsh dhone layak ho aur POISON likhi almari taale mein ho.
Application ke saath pharmacist ka State Pharmacy Council registration certificate aur appointment letter ya affidavit, premises ke ownership, tenancy ya occupation ka sabooth, site ya blueprint plan (Rule 65A ke tehat licensing authority use kabhi bhi maang sakti hai), firm ke constitution aur pehchaan ke kaagaz, aur storage tatha refrigeration ke intezaam ki declaration lagti hai. Retail pharmacy ke liye kisi class-10 certificate ki central shart nahi hai; matriculation plus chaar saal ke anubhav wala raasta wholesale ke competent person ke liye hai. Rajya apni checklist mein kuch aur items jodte hain.
Licence kitne din mein milega, iska koi samay Drugs Rules mein tay nahi hai; timeline rajya ke right-to-service vaadon se aati hai aur har rajya mein alag hai. Kholne ke total kharch ka bhi koi bharosemand sarkari aankda nahi hai, aur bazaar mein ghoomte andaze itne alag-alag hain ki un par budget banana theek nahi. Safe tareeka yeh hai ki kiraya, fitting, fridge aur opening stock ke quotation apne sheher se lijiye, yeh maan kar ki shelf ka bada hissa distributor ki credit par bharega. Shuruaat ka poora step-by-step medical store kaise shuru karein mein diya hai.
Medical store ke niyam par aksar poochhe jane wale sawal
Kya medical store ke liye registered pharmacist rakhna zaroori hai?
Haan. Rule 65(2) ke tehat prescription wali dawa registered pharmacist ki personal supervision mein hi bik sakti hai aur uska State Pharmacy Council registration current hona chahiye. PCI ne 13 December 2023 se registration ki Aadhaar authentication anivarya kar di hai, isliye kisi doosre ke certificate par dukaan chalana ab aasani se pakad mein aata hai; saza Section 27(d) mein 1 se 2 saal aur kam se kam ₹20,000 jurmana hai.
Kya dawa MRP se zyada daam par bech sakte hain?
Nahi. DPCO 2013 ke para 26 ke mutabik grahak se current price list ya label par chhape daam, jo kam ho, usse upar vasooli nahi ho sakti, aur para 27 ke tehat strip kaat kar di gayi dawa ka daam pro-rata se zyada nahi ho sakta. Ceiling price NPPA ki Pharma Sahi Daam service par jaanchi ja sakti hai.
Schedule H1 ka register kitne saal rakhna padta hai?
Teen saal, aur wo inspection mein dikhane ke liye taiyar rehna chahiye (Rule 65(3)(h)). Register mein doctor ka naam aur pata, mareez ka naam, dawa ka naam aur quantity darj hoti hai. Schedule H1 ki list ab 50 molecules ki hai, jisme Oseltamivir aur Zanamivir bhi shaamil hain.
Drug licence kitne saal mein renew karana hota hai?
2017 ke baad sale licence renew nahi hota. Rule 63 mein hue badlav ke baad licence tab tak valid rehta hai jab tak har paanch saal poore hone se pehle licence retention fee jama hoti rahe. Der hone par har mahine licence fee ka 2% judta hai, chhah mahine tak; uske baad licence deemed cancelled maan liya jata hai.
Expired dawa dukaan mein rakhne par kya hota hai?
Rule 65(17) ke tehat expiry ke baad dawa bechna aur stock mein rakhna, dono ullanghan hain; shelf par mil jana hi kaafi hai, bikri sabit karne ki zaroorat nahi. Wapasi ya disposal tak aisa maal trade stock se alag, upar "Not for sale" likhe cartons mein rakha ja sakta hai. Ullanghan Section 27(d) mein aata hai: 1 se 2 saal aur kam se kam ₹20,000 jurmana.
