ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has sought applications for the appointment of membership of the Central Licensing Board (CLB) for a period of three years, owing to the expiry of the tenure of current CLB appointed in 2022.
As per DRAP the eligibility criteria for CLB membership, individuals must possess relevant expertise in the pharmaceutical or medical field, as outlined in the DRAP Act, 2012, and the Drugs Act, 1976.
The eligibility criteria includes: (i) The roles and responsibilities of CLB members are defined in the DRAP Act, 2012, the Drugs Act, 1976, and the Drugs (Licensing, Registering and Advertising) Rules, 1976. The federal government appoints members to the CLB, with the qualifications, terms, and conditions being prescribed.
(ii) Members are expected to have expertise in pharmaceutical or medical fields. The CLB may co-opt other experts for advice on specific matters. The CLB can also include members from DRAP, provincial health departments, law specialists, and other medical and pharmaceutical experts from public and private institutions.
(iii) The CLB’s composition includes members from various backgrounds, including DRAP, provincial health departments, law specialists, and medical/ pharmaceutical experts. Representatives from the pharmaceutical industry can participate as observers in the meetings of the CLB. The Board may also include an expert in veterinary medicine, nominated by the Federal Government.
(iv) Members, other than ex-officio members, hold office for three years and are eligible for re-nomination.
Meanwhile, the DRAP with the approval of its Policy Board and the Federal has brought certain amendments in the Drug Pricing mechanism as specified in sub-clause (vii) of clause (c) of section seven read with clause (a) of sub-section (1) of Section 11 of the DRAP Act, 2012 (XXI of 2012). The mechanism is termed as Drug Pricing Policy, 2018.
This policy shall come into force at once and be applicable to the allopathic drugs and biologicals included in the National Essential Medicines List, for human use only.
Maximum Retail Price (MRP) of all drugs and biologicals included in National Essential Medicines List shall be fixed and regulated subject to procedures as specified in this Policy. All drugs and biologicals not included in the National Essential Medicines List are exempt from the operation of Section 12 of the Drugs Act, 1976 (XXXI of 1976).
List of drugs and biologicals in National Essential Medicines List may be revised after three years or earlier as deemed appropriate by the Authority in accordance with WHO list of essential medicines.
The MRP of a generic shall not, at any time, exceed the MPR of the respective Originator Brand except those cases where the Originator Brand has itself requested for deregistration or it is confirmed from the manufacturer or importer of the Originator Brand that they can no longer ensure the availability of the same due to the non-viability of the product,
No person including a retailer, hospital, clinic, wholesaler or distributor shall sell any drug to consumer at a price exceeding the MRP printed on the respective pack. In case of sale of a drug in loose quantity, MRP shall not exceed the pro-rata MRP printed on the respective pack.
No person including a manufacturer, importer, retailer, hospital, clinic, wholesaler or distributor shall be allowed to affix stickers, overlapping or masking of prices. However, in case of voluntary reduction in MRP, masking of previous MRP and reprinting of reduced MRP through laser inkjet will be permissible, if so requested. MRP fixation of Originator Brand of NCE & NBE in a particular dosage form, strength and delivery system shall be based on average price of the same dosage form and strength of the same brand in India and Bangladesh.
If the Originator Brand is available in only one of these countries, MRP shall be fixed at its par after considering the exchange rate parity. If Originator Brand of NCE or NBE has not been marketed in India or Bangladesh, its maximum retail price shall be fixed as under: (i) Average retail price of a basket of countries, namely; Indonesia, Philippines, Lebanon, Sri Lanka and Malaysia. If the Originator Brand is not available in all these countries, MRP shall be fixed at average retail price of the country(ies) in which Originator Brand is available; or if not available. (ii) MRP of Originator Brand of NCE/ NBE shall be fixed equal to average of the whole sale/procurement price available in the following: (a) UK Monthly Index of Medical Supplies or British National Formulary (BNF); (b) Australian Pharmaceutical Benefits Scheme; (c) New Zealand Pharmaceutical Management Agency; (d) If whole sale /procurement price is not available in any one or two of the above references, MRP shall be fixed at average of the whole sale/procurement price which is available in the remaining one or two references; or if not available. (iii) MRP of Originator Brand of NCE/NBE shall be fixed on the basis of trade price in the country of origin and grossed up for 15 per cent retailer margin; or if not available MRP calculated on the basis of formula in paragraph 9 or demanded MRP, whichever is lower.
Prices of new chemical entities in other countries shall be verified from any one of the independent sources as under.— (i) price information available on the official website of the regulatory authority or any authentic evidence to prove the retail price fixed by the regulatory authority of the respective country; or (ii) price information available in UK Monthly Index of Medical Supplies or British National Formulary or Australian Pharmaceutical Benefits Scheme or New Zealand Pharmaceutical Management Agency; or (iii) if price is not available as above, price of the same brand as certified directly to Division of Costing and Pricing, DRAP by any of the following agencies or organizations.—(a) Pakistan High Commission or Pakistan Embassy in the respective country; or (b) Any of top four global firms of chartered accountants operating in Pakistan through their member firms in the respective countries. (c) IQVIA. Since IQVIA maintains information on trade prices globally, it shall certify trade price in the respective country. (d) A format shall be devised by the DRAP to obtain the certified information on price (inclusive and exclusive of VAT, sales tax, excise duty or any other levy on sale of the drug) under sub-clauses (a), (b) and (c) above.
MRPs of generics of NCEs or NBEs.— (i) MRP of generics shall be fixed at 30 per cent less than the MRP of the Originator Brand, however, it may be reduced to 20 per cent in cases, wherein, compliance in respect of the regulatory requirements is established. This may include the establishment of Research and Development laboratories, submission of stability studies and comparative dissolution studies and the encouragement of cGMP compliance for local manufacturers.
MRP so fixed shall be applicable to in respect of an NCE or NBE of all generic substitutes and not a particular brand. (ii) if Originator Brand of an NCE is not marketed in Pakistan and a generic substitute is registered for marketing, its MRP shall be fixed at 30 per cent less than the Originator Brand MRP as per provisions of sub-paras (1) and (2) of para 4 and price verified as per provisions of sub-para (3) of para 4. (iii) if Originator Brand is not registered in Pakistan and its price information is not available as per provisions of sub-paras (1) and (2) of para 4, MRP of generic substitutes registered in Pakistan shall be fixed at average price in India (ceiling price of the drug fixed by the regulatory authority and if ceiling price is not available, retail price of the highest priced generic) and Bangladesh (retail price of the highest priced generic) and price shall be verified as per provisions of sub-para (3) of the para-4.
(iv) if Originator Brand is not registered in Pakistan and price information of Originator Brand and generics is not available in India and Bangladesh; MRP shall be fixed at average retail price of the highest priced generics of the basket of countries as listed in paragraph 4 (2)(i).
The DRAP said that after expiry of six years or till the time of entry of at least 3 generics/ biosimilars in the market, whichever is later, maximum retail price of the Originator Brand of NCE/NBE shall be reduced by 10 per cent per annum for three consecutive years (cumulative reduction of 30 per cent). MRP of any generic shall be at least 15 per cent less than the MRP of Originator Brand so reduced. However, if the average of the Originator Brand price in India and Bangladesh is lower by between 0 per cent to 30 per cent the price will be revised by that difference. MRP of specialised dosage forms and existing drug molecules with new delivery systems shall be dealt under the provisions of reference pricing method under this para. However, in case of any clarification which may be required by the Drug Pricing Committee, Registration Board being technical forum for this purpose will give its opinion.
According to DRAP, MRPs of new strengths of already registered drugs shall be fixed by applying the following formulae.—(i) Calculation of MRP of lower strength (new strength is of half of the existing strength) MRP = MRP of higher strength – 40 per cent; and (ii) Calculation of MRP of higher strength (new strength is double of the existing strength) MRP = (MRP of lower strengthx100)/60. MRPs of other strengths shall be calculated proportionately to the formula in sub-para (1).
MRPs of changed or additional pack sizes of existing drugs shall be calculated on pro-rata basis of already fixed MRP of the existing pack size of an oral dosage form or topical preparation or pack size with different number of injections of the respective drug/brand. In case the new pack size is two times of the existing pack size, MRP of new pack size, after calculation of pro-rata MRP shall be reduced by two per cent and four per cent reduction shall be applied if new pack size is triple or larger of the existing pack size.
Pharmaceutical concern may apply for additional/changed pack size of their existing registered drugs as specified in the sub-para (3) to the DRAP (Division of Costing and Pricing) and a confirmation of filing of application and calculation of MRP in accordance with the policy will be issued within 60 days of submission of the application.
In case of any correction or deficiency, the pharmaceutical concern shall make the correction within 30 days and resubmit the calculations and document. If no intimation or advice is sent to the applicant within 60 days, the applicant may market the additional or changed pack size at MRP calculated in accordance with this policy.
The MRPs of drugs containing combination of already registered drugs will be sum of MRPs of individual drugs and sum total reduced by five per cent. Reduction in MRP of Originator Brand.— (1) MRPs of Originator Brands of drugs and biologicals listed in National Essential Medicine List shall be reduced by 10 per cent per annum for three consecutive years (cumulative reduction of 30 per cent) of MRPs as fixed by the federal government except the following.- (i) Where less than three generics are available in the market. (ii) Lower priced Originator Brands as defined in para 10.(iii) Originator Brand where average retail price (exclusive of vat, sales tax, excise duty or any other levy on sale of the drug) of the same brand in India and Bangladesh is higher at the time of reduction. In case, the Originator Brand is available in one of these countries, retail price (exclusive of vat, sales tax, excise duty or any other levy on sale of the drug) in that country shall be taken as reference for this purpose. If average price of the Originator Brand in India &Bangladesh is lower by between 0 per cent and 30 per cent then MRP will be reduced by that difference and simultaneously will be netted off over the applicable annual increase under this Policy. In case the Originator Brand is available in one of these countries, retail price in that country will be taken as reference for this purpose.
(iv) Where Originator Brand has not been marketed in India or Bangladesh its MRP is not higher than the lowest of the following, namely.— (a) Retail price (exclusive of VAT, Sales Tax, Excise Duty or any other levy on sale of the drug) in basket of countries as listed in para 4(2)(i); (b) Wholesale price in UK Monthly Index of Medical Supplies or British National Formulary or Australian Pharmaceutical Benefits Scheme or New Zealand Pharmaceutical Management Agency (exclusive of VAT, sales tax, excise duty or any other levy on sale of the drug); and (c) Originator Brands for which bona fide hardship application are under
If MRP of any Originator Brand has already been reduced or frozen for 15 or more years by the Federal Government or the manufacturer or importer itself, any such earlier reduction or freeze by the Federal Government or the manufacturer or importer itself shall be adjusted while calculating reduction under sub-para (1). However, annual increase linked with CPI shall not be granted to such Originator Brands from years 2015 to 2019. Thereafter, from July, 2019 these Originator Brands will be entitled to such annual increase. MRP of any generic shall be at least 15 per cent less than the MRP of Originator Brand so reduced under sub-para (1) and generics where lower MRPs have been fixed shall not be allowed to increase their MRPs except any increase as expressly allowed under this Policy 7. Annual adjustment in MRPs of drugs.— (1) Annual increase in MRPs of drugs has been linked with CPI of the immediately preceding financial year. (2) Manufacturers and importers may increase their existing MRP’s of essential drugs/biological (excluding lower priced) equal to 70 per cent increase in CPI (with a cap of 7 per cent) and MRPs of lower priced drugs up to increase in CPI (with a cap of 10 per cent) subject to the following conditions, namely:- (i) calculations of revised MRPs, duly signed and stamped by the Managing Director or Managing Partner or CEO or any authorized person on his behalf, shall be submitted along with evidence for authenticity of existing MRPs to the Authority (Division of Costing and Pricing). Non intimation of MRPs shall be construed as non-revision of MRPs. The failure to submit the calculations for increase in MRPs shall tantamount to nullifying the price increase; (ii) if calculations of revised MRPs are in accordance with this sub-paragraph, the authority shall issue the revised price within 30 days of submission of the correct calculations by the manufacturer or importer provided that where the Authority fails to issue revised price within the mandatory period of 30 days, such issuance shall be deemed to have been made; (iii) revised price list shall be submitted in hard copy and upon issuance shall be uploaded on the DRAP’s website or as prescribed by the Authority from time to time; (iv) no manufacturer, importer, retailer, hospital, clinic, whole-seller or distributor shall be allowed to affix stickers overlapping or masking of prices; (v) the price increase shall not be applicable on the batches manufactured before affecting the increase under this paragraph. No recall of drugs of already marketed batches shall be allowed; (vi) the revised MRPs shall be printed on the label in the manner prescribed by the Drugs (Labelling and Packing) Rules, 1986; and (vii) if there are cogent reasons why the MRP of a drug/biological should not be increased or reduced, the federal government may, by notification for reasons to be recorded, declare a specific category of drugs/biological to be excluded from application of this sub-paragraph.
MRPs of the generic(s)/ biosimilar(s) fixed by the Drug Pricing Committee of the Authority or Drug Pricing Committee or Price Advisory Committee or Price Recommendatory Committee of the Ministry of Health (defunct) shall be applicable to new entrants of the same drug. However, the manufacturer or importer may submit calculations of its MRP with DRAP, (Division of Costing & Pricing) to adjust MRP notified on registration letter under sub-rule (4) of rule 29 of the Dugs (Licensing, Registration and Advertising) Rules, 1976 with applicable rate of increase or decrease on the basis of CPI as allowed under Drug Pricing Policy-2015 or this Policy subject to conditions laid down in para 7 of this Policy.
MRPs of new entrants of the drugs already available in the market which have not been fixed so far by the Drug Pricing Committee of the Authority or Drug Pricing Committee or Price Advisory Committee or Price Recommendatory Committee of the Ministry of Health (defunct) shall be fixed at the time of registration according to the following parameters. (i) MRP of generic(s)/ biosimilar(s) shall be fixed at 30 per cent of the MRP of the Originator, however, it may be reduced to 20 per cent in cases, wherein, compliance in respect of the regulatory requirements is established. This may include the establishment of Research and Development laboratories, submission of stability studies and comparative dissolution studies and the encouragement of cGMP compliance for local manufacturers. MRP so fixed shall be applicable to in respect of all generic substitutes and not a particular brand. (ii) In case generic(s)/ biosimilar(s) of a drug are already available in the market but MRP of the drug has not been fixed so far by any of the above said committee, MRP shall be fixed at the highest MRP of a generic brand of the same drug/biological already available in the market. (3) If strength of drug(s) in a tablet is equal, same MRP will be fixed for its all coated and un-coated forms. (4) If strength of drug(s) in a capsule as powder or pellets is equal, same MRP will be fixed for its all hard forms. (5) If strength of drug(s) in a liquid oral dosage form is equal, same MRP will be fixed for its all liquid dosage forms. (6) If strength of drug(s) in optic or ophthalmic or nasal dosage form is equal, same MRP will be fixed for its all liquid dosage forms. (7) If strength of drug(s) in a topical dosage form gel/ cream/ ointment/ paste/lotion/ liquid) is equal, same MRP will be fixed for equal pack sizes in grams/millilitres, etc.
If contents of drug(s) in an injection are equal, same MRP will be fixed for its vial or ampoule irrespective of its filling in glass or plastic or Low Density Polyethylene (LDPE) or any other material up to 20ml pack size. (9) If strength of drug(s) in a tablet or capsule in a modified release form is equal, same MRP will be fixed for its all modified (sustained/ extended/delayed/ core-coated/ prolong /slow) release forms. (10) If MRP is fixed for base, then same MRP will be considered for the salt as approved by reference regulatory authorities as adopted by the Registration Board.
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