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	What is import registration? What are the products that fall under the preview of the import registration? Who can apply for the registration of the foreign manufacturer and products manufactured therein? What are the documents required for a registration certificate application? What is the registration fee for the foreign manufacturing unit and each product? How and where the fee is to be deposited for the registration? Can equivalent amount of Indian Currency be deposited as Registration fee? How the fee for registration of products will be calculated? What should be the manner of labelling of the products? Can products covered under Drugs & Cosmetics Rules be imported on a “Neutral Code”? What is the time period required for the registration? What is the validity period of registration Certificate? Do a re-registration is sought after three years? What is an import license? What is the validity period of Form 10? What is GEAC? What is Rule 122A/122B/122D/122DA/122E approval? What is the "Drugs (Prices Control) Order (DPCO, 1995)"? What is NPPA and its role? Are all the drugs marketed in the country fall under price control? Whether NPPA has any role to regulate prices of non-scheduled drugs? What margins are allowed to a Wholesaler and a Retailer as per DPCO, 1995? Who are the national level, state level and district level authorities those are responsible for enforcement of fixed prices? Where can a consumer lodge a complaint regarding overcharging and quality of drugs sold? What is a retail price? What is the methodology for fixation of bulk drug price? What is the methodology for fixation of price of formulation? What is Suo-motu pricing? What is Pro-rata Pricing? What is a Medical Device? What is an accessory to a medical device? What is MDD? What is EC Directive 93/42/EEC? What is 98/79/EC?
	What is import registration? The registration of the manufacturing site of a foreign manufacturing unit and the products manufactured therein, intended for import into India under the Drugs & Cosmetics Rules.
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	What are the products that fall under the preview of the import registration? All the biological & non-biological drugs, including bulk drugs, finished formulations, vaccines, critical diagnostic kits, syringes, needles, sutures, catheters, medical devices and internal prosthetic implants.

	Who can apply for the registration of the foreign manufacturer and products manufactured therein? Application for Registration Certificate can be made either by their own office in India or by his authorised agent in India. These applicants must have either a wholesale drug licence or a manufacturing licence.

	What are the documents required for a registration certificate application? The documents should accompany bank challans showing requisite fee paid, Form 40, Power of Attorney to the Indian Agent/Office and dossiers as per Schedule D (I) & D (II).

	What is the registration fee for the foreign manufacturing unit and each product? The registration fee is US $ 1500 per manufacturing site to be registered and US $ 1000 per product to be registered.
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	How and where the fee is to be deposited for the registration? The fee can be either transferred(SWIFT TRANSTFER/TT) directly into the account of Pay & Accounts Officer, DGHS, New Delhi or can be paid by the way of Demand Draft in the favour of Pay & Accounts Officer, DGHS, New Delhi at Bank of Baroda, K.G.Marg, New Delhi. The fee can also be paid in other following locations as well: Bank of Baroda, Horminal Circle Branch, P.M.Road, Fort, Mumbai Bank of Baroda, Chennai Main Branch, Rajaji Salai, Chennai Bank of Baroda, 4, India Exchange Place, Kolkata

	Can equivalent amount of Indian Currency be deposited as Registration fee? Yes. As per prevailing rate of the US $ on the day of deposit can be paid in Indian Currency as well.

	How the fee for registration of products will be calculated? Each bulk drug in its base form or salt form or ester form will be taken as one drug. Each formulation in its specific dosage form will be a single drug. Another brand name will be considered another product. Each group in the device are of same material, have similar application & same design certificate under EC norms.
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	What should be the manner of labelling of the products? The labels should be as per Drugs & Cosmetics Rules, 1945. The labels should have following information in English Language: Product Name/Brand Name Composition Sterile/Non-sterile Batch No. /Lot No. Manufacturing Date Expiry Date Name and address of the manufacturer. Storage & Transportation instructions. Maximum Retail Price

	Can products covered under Drugs & Cosmetics Rules be imported on a “Neutral Code”? No.

	What is the time period required for the registration? As per Drugs & Cosmetics Rules the registration process will take 9 months of time.

	What is the validity period of registration Certificate? The registration certificate is valid for the period of three years from the date of issue, unless it is sooner suspended or cancelled.
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	Do a re-registration is sought after three years? Yes. For the re-registration of manufacturing site along with their manufactured products, a fresh application of registration certificate is made nine months before the expiry of the existing certificate and the current registration certificate shall be deemed to continue in force until orders are passed on the application.

	What is an import license? The Form 10 is an import license. The same can be obtained by any Indian agent/distributor/manufacturer having valid wholesale drug license or manufacturing license. The Indian agent has to apply on Form 8 and Form 9 has to be issued by the company having valid Form 41 along-with a Fee of Rs 1000 for the first product and Rs 100 for every additional product.

	What is the validity period of Form 10? Form 10 is valid up till the validity of Form 41 unless it is sooner suspended or cancelled.

	What is GEAC? It is ‘Genetic Engineering Approval Committee’ and LMO’s are required to get through the approval of this said Committee before permission being granted by DCGI under Rule 122A.

	What is Rule 122A/122B/122D/122DA/122E approval? Any new drug entering in Indian market has to have a New Drug Approval under Rule 122 of Drugs & Cosmetics Rules, 1945.
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	What is the "Drugs (Prices Control) Order (DPCO, 1995)"? The DPCO (Drugs Prices Control Order, 1995) is an order issued by the Government of India under Essential Commodities Act, to regulate the prices of drugs. The Order provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by Govt., penalties for contravention of provisions etc. For implementing provisions of DPCO, powers of Govt. have been vested in NPPA.

	What is NPPA and its role? National Pharmaceutical Pricing Authority (NPPA), was established in August 1997 as an independent body of experts as per the decision taken by the Cabinet committee in September 1994 while reviewing Drug Policy. The Authority has been entrusted with the task of fixation/revision of prices of pharmaceutical products (bulk drugs and formulations), enforcement of provisions of the DPCO and monitoring of the prices of controlled and decontrolled drugs in the country.

	Are all the drugs marketed in the country fall under price control? No, Only 74 out of about 500 commonly used bulk drugs are kept under statutory price control. All formulations containing these bulk drugs either in a single or combination form fall under price controlled category. However, the prices of other drugs can be regulated, if warranted in public interest.

	Whether NPPA has any role to regulate prices of non-scheduled drugs? The manufacturers of non-scheduled drugs (drugs not under direct price control) are not required to take price approvals from NPPA for such drugs. However, NPPA is required to monitor the prices of such drugs and take corrective measures where warranted and they have power to fix and regulate such prices.
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	What margins are allowed to a Wholesaler and a Retailer as per DPCO, 1995? For scheduled (controlled) drugs the margin is fixed at 16% as per para 19 of the DPCO, 1995 which is reproduced below: "A Manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of this order or any order made thereunder, at a price equal to the retail price, as specified by an order or notified by the Government, (excluding excise duty, if any) minus sixteen per cent thereof in the case of Scheduled drugs". "Notwithstanding anything contained in sub-paragraph (1), the Government may by a general or special order fix, in public interest, the price of formulations sold to the wholesaler or retailer in respect of any formulation the price of which has been fixed or revised under this Order". For non-scheduled formulations the companies are at liberty to decide the margin. However, it is reported by the industry that the prevailing normal trade margin in respect of some decontrolled formulations is 20% for retailers and 10% for wholesalers.

	Who are the national level, state level and district level authorities those are responsible for enforcement of fixed prices? The National Pharmaceutical Pricing Authority, the FDA/ Drugs Controller of the State and Drugs Inspector of the District are the enforcing authorities at National / State/ District Levels.

	Where can a consumer lodge a complaint regarding overcharging and quality of drugs sold? Charging more than printed MRP of a medicine attracts the penal provisions of Drugs Price Control Order, 1995. Quality aspects of a medicine attract the provisions of Drugs and Cosmetic Act, 1940. The FDA/ Drugs Control Organization of the State are the enforcing agency of Drugs and Cosmetics Act and DPCO at state level. Therefore, all complaints on prices as well as quality of medicines can be lodged with the Drugs Inspector of the District or the State Drug Controller. Complaints regarding violation of prices can be lodged with NPPA directly also.
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	What is a retail price? A retail price is a price at which a medicine is sold to a consumer/user. The manufacturer of the medicine is required to print such a price on the label of the product. In case of controlled formulations the retail price is a price arrived at or fixed in accordance with the provisions of Drugs (Prices Control) Order, 1995.

	What is the methodology for fixation of bulk drug price? Methodology for fixation/revision of bulk drug prices is as under: As per para 3 of DPCO, 1995, bulk drug prices are fixed by the NPPA to make it available at a fair price from different manufacturers. These prices are fixed from time to time by notification in the official gazette. The following steps are involved in fixation/revision of bulk drug prices:- Collection of data by issuing questionnaire/Form I of DPCO, 1995 to the companies and from cost-audit report etc. Verification of data by plant visits, when required. Preparation of actual cost statement. Preparation of technical parameters to be adopted for working out fair price of the bulk drug. Preparation of estimated cost based on actual cost and technical parameters. Fair price is calculated by providing returns as specified in sub para (2), para 3 of DPCO, 1995 as opted by the individual manufacturer. Fixation of fair price of bulk drug by considering weighted average cost, °rd cut-off level of production studied. Notification of bulk drug price in official Gazette. The fair prices may be further revised, if asked for by the manufacturers, based on escalation formula for change in major raw materials and utilities rates.
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	What is the methodology for fixation of price of formulation? Para 8 of DPCO, 1995 lays down the rules and procedure for fixing prices of formulations. Para 7 of the DPCO lays down the formula for calculation of retail price of formulation. The circumstances that warrant price fixation of formulation are :- Revision in the prices of bulk drugs(Sub-Para(2) of para 8 of DPCO, 1995) Introduction of new packs ( Sub -Para (6) of para 8) Change in various norms etc. notified by Government under para 7. Other reasons which may be cited by the manufacturer. In order to seek price approval, the firm manufacturing the pack has to make an application in Form -III appended to the DPCO, if it is locally manufactured; or Form-IV, appended to the DPCO, 1995, if it is imported. Applications received in NPPA from manufacturers in Form III for indigenous formulations and from importers in Form IV (as prescribed under DPCO, 1995) are considered for price fixation/revision. The retail prices of indigenously produced formulations are worked out as per the formula given in para 7 of the DPCO, 1995. For indigenously manufactured formulations, the Maximum Allowable Post-manufacturing Expenses (MAPE) is allowed upto 100%. For imported formulations MAPE is upto 50% of landed cost.

	What is Suo-motu pricing? The NPPA also fixes/revises prices of both bulk drugs and formulations on suo-motu basis, where it is felt that manufacturers are not filing their applications as per the provisions of the DPCO, 1995 after the decrease in bulk drug prices and statutory duties, etc. Hence, with a view to passing on the benefits of such decreases to the consumers, suo-motu price is fixed. For example, as per para 8(2) of DPCO, 1995, the manufacturers are to apply for price revision of formulations within a period of thirty days of price fixation/revision of bulk drug(s). If they fail to comply with this during the prescribed time, suo- motu action is taken as per para 9(2) of DPCO, 1995 for ceiling prices and as per para 8(2) and para 11 of DPCO, 1995 for non-ceiling packs.
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	What is Pro-rata Pricing? NPPA has issued notification on pro -rata pricing on 27.01.98. According to this notification, the manufacturers of all the scheduled formulation pack sizes different from the notified pack sizes under sub- paragraphs (1) and (2) of the paragraph 9 of the DPCO, 1995, shall have to work out the price for such pack sizes, in respect of tablets and capsules of the same strength or composition packed in different strips or blisters, on pro-rata basis of the latest ceiling price fixed for such formulations under sub-paragraphs (1) and (2) of para 9 of the DPCO, 1995. This was done to ensure that:- manufacturers are not forced to approach frequently for price approvals for different pack sizes and The manufacturers do not change the pack sizes in a bid to remain out of price control. Every formulation of a bulk drug included under schedule 1 of DPCO, irrespective of pack size, strength, dosage form must be marketed only at price fixed by Government, with adjustment for pro-rata price wherever required. However, the manufacturers in the Small Scale Industry (SSI) category may avail exemption from seeking price fixation from NPPA in respect of Scheduled Formulations not covered under ceiling prices provided they have submitted a declaration to NPPA as per S.O.No.134 (E) dated 2nd March, 1995 and obtained approval for the same from NPPA.

	What is a Medical Device? Medical Devices are instruments, appliances, apparatus, materials or other articles including software for the diagnosis, prevention, monitoring, treatment or alleviation of diseases or compensation for injuries or handicaps, investigation, replacement or modification of anatomy or of a physiological process & control of conception.

	What is an accessory to a medical device? Articles that are not medical device themselves, but are used in conjugation with a medical devices. These objects can be classified separately according to Annex IX of the Medical Device Directive.
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	What is MDD? The Medical Devices Directive (MDD) covers the mandatory regulatory requirements of the European Union for Medical Devices to fulfill CE certification requirements in order to export medical devices, of Class I, IIa, IIb, and III to any country within the European community. Compliance with the requirements of the Medical Devices Directive is declared by placing the CE Marking on the product, and supplying the device with a Declaration of Conformity.

	What is EC Directive 93/42/EEC? The 93/42/EEC Directive is Medical Device Directive sets general requirements and requirements relating to the design and construction of medical devices. The directive applies to all medical devices, except for active implantable medical devices. The separate active implantable medical device Directive is applicable to them (90/385/EEC).

	What is 98/79/EC? The 98/79/EC Directive is defined as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”.
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