Agenda 252nd Registration Board Meeting

Agenda for 252nd Meeting Registration Board to be held on 07-08th September, 2015.

Item No.Detail of Item

Item No.IConfirmation of minutes of 251st meeting Registration Board

Item No.IICases referred by Biological Drugs Division

Item No.IIICases referred by Pharmaceutical Evaluation & Registration Division

Any other item with permission of Chair

Item No. I: Confirmation of minutes of 250th meeting Registration Board.

251st meeting of Registration Board was held on 12-13th August, 2015. Draft minutes were circulated to all members (who attended the meeting) through e-mail with the request to forward their comments (if any) within 05 days. Dr.Khalid Khan, Director DTL, Peshawar forwarded following comments:

Agenda item No II. Case No.1 Court case of rBGH or Rbst:

Before taking the decision on safety of the rBST or rBST i shall bring in the notice of board 8 shocking facts about BGH or rBST published on Jan. 2014. since BGH received FDA approval in 1993 three disturbing health trends have emergeda) cancer cases continue to increases.b) obesity has been an epidemic.c) an early onset puberty has become norm.

RRR Division. Case No. 01 Re-registration of drugs:

Wrongly depicted the agenda item in the 251stmeeting working paper as Registration instead of renewal of expired certificate of Registration.

As mentioned in Rule 27 chapter III Registration of drugs, Drugs (L.R.&A) Rules 1976. The certificate for registration of drugs period is five years from the date of registration of drug and may thereafter be renewed for period not exceeding five years i.e, continuous processes till the withdrawal of registration by firm or suspension/ cancellation by the competent forum or as the case may be. Themod-usoperandifor renewalof registration is that an application has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years. It was worthwhile to mention The Rules 1976 are silent regarding fail to apply for renewal of registration of certificate in time or expired for next five years due unfavorable circumstances or otherwise.

The article 254 of constitution of Pakistan clearly redress this issue as under:

Failure to comply with requirement as to time does not render an act invalid. When any act or thing is required by the constitution to be done within a particular period and it is not done within that period. The doing of the act or thing shall not be invalid or otherwise ineffective by reason only that it was not done within that period

Keeping view the essence of Article 254 all the pending applications of firms whos failed to apply for renewal in time and expired may be reconsidered and approval may be accorded by board with full fee as required under Law.

Submitted for consideration of Registration Board.

Item No.II:Cases referred by Biological Drugs Division.

Case No.0 ICOURT CASE OF RECOMBINANT BOVINE GROWTH HORMONE (rBST OR rBGH)The case of rBST containing Registered Products is in the Honorable Lahore High Court. The decision of 251st Board Meeting is as follows;After due discussion and deliberations in Registration Board, it was decided to continue with the registration of rBST containing products as the safety and efficacy profile of the drug reported in the available scientific data is in acceptable limits. However, to the point raised for more data on buffaloes, the Registration Board decided to carry out a multi-centred, controlled trial in buffalos, particularly to ascertain the relation of rBST use with incidence of mastitis, under supervision of the Vice Chancellors of at least three public sector Universities of Veterinary Sciences. The trials will be completed within six (6) months and the decision can be reviewed in the light of data generated by these studies.2.In light of case discussion and decision in the 251st Meeting of Registration Board, report was submitted before the Honorable Lahore High Court. The Court has passed following orders on 26.08.2015;.2. The DRAP to convene the meeting of the Drug Registration Board on 31.08.2015 at 9:00 A.M. The objections filed by Government of Punjab which are already pending before the DRAP should be considered by the DRAP and if the Petitioners file their objections within time before 31.08.2015, the same may be heard as well. All the parties including the distributors should appear before the Board on 31.08.2015 at 9:00 A.M. for which date notices be issued to all concerned by the DRAP 3.Due to time constraints the Meeting could not be held on 31.08.2015. Further, the Petitioners did not submit any objections or data for consideration of the Board before 31.08.2015. However, a fresh reference has been received from the Secretary (L&DD), Government of Punjab on 25.08.2015. The meeting was scheduled on 07.09.2015 and notices of meeting were issued to all the concerned on 31.08.2015. The report was submitted to the Lahore High Court on 01.09.2015 explaining the position. 4.The Secretary (L&DD), Punjab being respondent in the writ petition has submitted fresh reference (dated 25.08.2015) which is reproduced as under; Subject:USE of rBST AND ASSOCIATED ISSUES.Kindly refer to the subject cited above and directions, dated 19.8.2015, of the Honourable Lahore High Court, Lahore in Writ Petition No. 10663/15 titled Surfraz Ahmed Vs. FOP etc., The AG Office, Punjab vide letter No. 17124/ AG, dated 19.8.2015 (Copy enclosed at Annex-A) communicated the directions of the Honourable Court for the Government of the Punjab to provide:i. its own information;ii. reasons/ data,Which formed the basis of reaching the conclusion that the drug in question is injurious and harmful to:-a. sustainable production capacity of the Livestock Sector;b. harm to the human life.

PRELIMINARY OBJECTIONS: The DRAP skipped the actual view point of the Punjab Government and did not include the major issues raised during the proceedings of the meeting is a big question mark. The undersigned pointed out the following:1. Before start of the meeting, to influence the decision making of the Registration Board and to favor the representatives of both the companies, the CEO DRAP at the very outset of the meeting consumed 32 minutes for propagation of the hormones in question. The undersigned was left with no choice but to register protest on this unethical and biased conduct, which was not even warranted by the rules of business. The Chairman committed to incorporate this episode in the minutes and report but there is no mention of the same.2. During the start of the meeting, the CEO DRAP was apprised by the undersigned that he had held and unofficial meeting with both the companies a day before i.e. on 12th of August, in absence of any of the representatives of the Punjab Government.3. The issue of Fish Powder was very much on the agenda but it was not discussed. So much so that the undersigned had to remind Chairman and the Board regarding the issue but the same has been skipped from the report.4. The Registration Board was informed that 3 out of the 5 foreign representatives of both the companies did not had approvals of use of rBST for their own countries and how they can recommend the same for Pakistan. Furthermore, the Board was apprised that in the US i.e. the country of origin, the rate of pasteurization/ UHT for milk is 100% done to ensure the food safety standards as per their law. In Pakistan, more than 96% milk reaches the consumer unprocessed i.e. it contains puss cells, residues of anti-biotics and hormones used in animals. Hence, the comparison is only possible when we guarantee the US processing capacity and standards.5. The literature of the company (Annex-B), itself mentions that it is for healthy lactating DAIRY COWS ONLY. It clearly mentions effects of the drugs i.e.a. Reduced pregnancy ratesb. Increased days openc. Increased mastitis (visibly abnormal milk)d. Higher somatic cell counte. Increased body temperature not related to illnessf. Lower body conditiong. Disorders of hocks and foot regionh. Reduced hemoglobin and hematocrit valuesi. Udder edema hence more therapeutic treatment and drugs usej. Swelling of injection sitesk. Slaughtering prohibited till 7 days of use of injectionThe involved complications ended up decline in its use even in the country of origin. The overall percentage of cows that received rBST decreased from 22.3% in 2002 to 17.2% in 2007 (USDA APHIS VS/73) (Copy Annexed at Annex-C). The decline in use and reaction by the EU and 90% countries of the world forced the company to dispose of it product to some other company to get rid of it.6.As confessed by the companies that the said hormones are being administered mainly to the buffalo population i.e. 90%, the Department highlighted the following facts:a. The fate of animals of Pakistan, especially the water buffalo along with local and exotic cows, already living in the extreme weather conditions, can be evaluated with the fact that use of this hormones adds to the misery of the animals by further raising their body temperature unnecessarily with no solutions proposed.

7. The companies admitted upon enquiry by the undersigned that they maintain the data of the users, sellers and their stockists. The factual position about the sale and use of this drug at human medical stores and by quakes administering the same to the human beings. No explanation was extended or recorded in the report. The list of some of the human medical stores, involved in this heinous crime was handed over to the companies and the Chair along with copy of the FIR but the same could not find its place in the report. (Copies enclosed as reference as Annex-D).

8. The undersigned apprised the Board that there are rumors that after the meeting on 12th of August, 2015 of the CEO DRAP with the companies, original record relating to the subject drugs has been removed as an attempt to conceal facts from the Honourable Court. The Chairman publically committed to provide copy of the same to the undersigned on the same day so as the undersigned could frame reply but despite reminder till late night, the Chairman confessed that the record is not traceable. This very important fact has been concealed from the Court in the report as no such report could be generated in the absence of such basic record. The gentleman namely Dr. Usmani who happened to be the Animal Husbandry Commissioner for quite a long time, allegedly maneuvered the registration of a non-therapeutic hormone beyond the legal competency of the drug registering authority. Astoundingly, he was representing one of the companies pretending himself to be their employee but in fact he was partner of the company and reaping the associated benefit at the cost of the poor farmers interest. This irony also not found its place in the report.

9. The company representatives failed to reply the query about the devised mechanism for the disposal of milk infected with puss and anti-biotic residues for which the company itself recommends 72 hours as withdrawal period, meaning thereby the public under ignorance is being forced to consume milk of animals, with higher incidence of mastitis, as stated by Dr. Makhdooms research report page No. 2, published by PARC, which confirms prevalence of mastitis was 57.14% higher in rBST treated animals, infested with puss and anti-biotic residues.(Annex-E)

10. The reports on the issue, of the Bahaudin Zakariya University Multan and Agriculture University Faisalabad, were presented and copies handed over during the discussion. The physiological and anatomical differences in the structure, formation and functioning of cows and water buffalos, being distinctly different species, reported by Prof. Dr. Masood Akhter, Dean, Faculty of Veterinary Sciences, BZU, Multan also could not find its even mentioning in the report be it in the form of rebuttal. Reasons are not known. (Copy of the said reports are annexed at Annex-F & G, respectively).

11. The Board was apprised about the maneuvered reports; misrepresentation of facts of the claimed trials: one maneuvered by the ICI at Patokki and the other by the Gentleman representing the local company. The original data and registers were presented for verification of the wrongly stated facts but the same was also skipped conveniently. Copies of the data showing the havoc wreck by the hormone to the animals with unprecedented mortality ratio caused physical disorders and ultimate fate ending up in disposal of animals. The original record will further be produced in the Court for fact finding.

OBJECTION ON THE REPORT1.THE SCOPE OF DRAPS REPORTa.FISH POWDER SKIPPEDDespite being on the agenda item, the Fish Powder was deliberately skipped. No approval, literature on the said hormones, which is being widely used in the Punjab, was made available by the company. Hence, the mystery surrounding the origin, nature, use and approval of Fish Powder needs to be elaborated by the DRAP.b. DEFECTIVE COVERAGE OF THE SCIENTIFIC DATA

i. Technical Details and deliberations (Pharmaceutical Dossier, Assessment, data presented) thereon skipped;ii. The data presented by the undersigned, regarding defenders own quaoted studies/ trials at L&DDs Experiment Stations, depicting a heinous picture of out of the trials of rBST on animals were deliberately skipped, posing a big question mark on the scientific integrity of whole process of evaluation. Following trials at BRI, Pattoki and LPRI, Bahadanagar, Okara as per claim of the paid research with maneuvered results, the facts are preserved n the original registers/ record:1. BRI, Pattoki: experiment was conducted on 25 controlled and 25 treated buffalos from 30.10.2013 to 31.05.2014. The ICI financed and paid budget amounting to Rs. 4.43 million. The record exposes the claimed impact as under:

a. 20 treated animals against compared with 6 controlled out of batches of 25 each, suffered mastitis. The increased incidence is thus 80 in treated animals with rBST and 21% n the controlled batch. (Annex-H)b. 15 treated animals received 2-5 services i.e. decreased conception rate. (Annex-I)c. The service period of 17 treated animals was 4-16 months against a normal of 3 months i.e. increased service and calving interval. (Annex-J)d. After rBST trial, the birth weight reduced by 5 Kg on average, two dead births, two teat and udder damage and ten have not yet calved after the trial. (Annex-K)e. The treatment details depict the severity of mastitis in rBST treated animals as steroids and even formalin had to be administered to control the phenomenal infection. (Annex-L)f. Interestingly the general public kept consuming the milk produced with more puss, hormone, anti-biotic residues and FORMALIN.

2. The trials at LPRI, Bahadarnagar: it was a remote control trial managed by the said Dr. Usmani, who was the Animal Husbandry Commissioner, happened to have remained posted at the said station and succeeded in maneuvering the shifting of trial site from Sindh Province to LPRI, Bahadarnagar, Okara, As confirmed, he never visited the LPRI during the trial except fabricating the data and sharing the same with another partner who was also away. The fabricated data presented by Dr. Usmani and published thereafter is in contravention with the original data contained in the official registers, which was duly produced in the DRAP Boards meeting and alarms as under:

a. The study was conducted (Annex-M) from Dec. 2004 to June 2007 at LPRI Bahadarnagar, Okara on Nili-Ravi Buffaloes, The sample size of treated and controlled animals was 15 each and the study titled Effect of long term use Bovine Somatotropic Hormone (BST) on milk production, reproduction health and physiological parameters in Nili-Ravi Buffalo. The milk production of the treated group showed a decrease of 7,238 litters during 1st and 2nd lactation and 10.556 liters reduction in 2nd and 3rd calving against which the controlled group showed reduction of 4930 liters during 1st and 2nd lactation and 4,683 liters in 2nd and 3rd lactation i.e. the impact of the rBST was observed negative in milk production with advancing lactation as the treated group showed a decreased production of more than 40% of milk in 2nd and 3rd lactation hence, it diametrically opposes the claim.b. The treatment record, confirms that 12 out of 15 animals suffered foot wound, and lameness, which is 80%. The tits swelling, eye and foot wounds, tympany, colic, increased body temperature, blood from ear, nose, Theileriosis, RFM, tail wound, weakness, thin milk and much more remained the hall mark of the trial due to which the Department had to suffer and irreparable loss as even the steroids failed to ameliorate the situation. (Annex-N)

iiiData regarding extra label use of the drug was not considered .1. Data on its use in male buffalo calves i.e. for feedlot fattening (Annex-O)2. Data on its use in Sheep & Goat (Annex-P)iv. Data regarding the use of drug in contravention of the Federal Law of the country of origin was skipped. The Government of the Punjab is considering approaching the FDA regarding extra-label use of this drug by the company and other importers to claim damages purported to poor ill-informed farmers and dairy breeders in violation of the law of the land.v. No. data regarding bio equivalent studies etc. exists as per the mandatory clause of DRAP Act, 2012.vi. Misuse and mis-interpretation of data of experiments has been proved on both the studies maneuvered by the companies. The Department is approaching the HEC and Higher Education Department for taking legal action against the fraudulent move.vii. Against the claim of the company, the OCT sale of this hormone at human medical stores with free access by the quakes has also been reported to the health Department. (Annex-Q)

c. ECONOMIC ASPECTS OF DRUG ON SECTOR DEVELOPMENT AND FARMERS SKIPPED

i. The corporate sector was forced due to the colossal damage to their livestock after the use of this hormone in their exotic cattle during 2002-2010. This devastation has now turned into closing of the business. The representatives of the company even confessed that at present no corporate dairy having exotic cattle or Military dairies is using this hormone.ii. Small subsistence farmers, who constitute more than 80% of the total livestock breeders, are illiterate; cannot afford quality controls of management of disease and environmental controls hence are at the mercy of exploitation with knock out effect.

3. THE LEGAL FRAMEWORKa.THE PREVENTION OF CRUELTY OF ANIMALS ACT, 1890The Act explicitly stipulates up 2 years imprisonment and fine and forfeiture of the animal to the Government if subjected to the introduction of any substance into the female organ of a milch animal with the object or drawing off the animal any secretion of milk. Hence, no question of using any substance can be allowed on animals for milk secretion being in contravention of the said Act, In the presence of this already existing Law, the Registration Board of DRAP cannot register rBST in the first place. This is extremely important and significant aspect of animals prevention of cruelty and also as per the admission of Dr. Glenn Kennedy, the representative of ICI, given at page 19 of DRAPs report, the European Commission has banned the use and marketing of rBST from 1st January 2000 on animal health and welfare ground.b. REGISTRATION OF rBST BY REGISTRATION BOARD OF DRAPAs per oxford Advanced Learners Dictionary, therapeutic means designed to help treat an illness. It is worth mentioning here that EU does not allow the use of rBST in animals, besides other reasons, due to the reason that it is not therapeutic drug and the same fact was admitted by Mr. Glenn Kenndy, the respenstative of ICI and his admission was duly incorporated by DRAP in its very report at page seventeen. As per the DRAP Act, 2012, the registration Board means a Registration Board to regulate the grant of registration to therapeutic goods. Thus on this very count, DRAP s Registration to Board cannot entertain rBST registration or renewal as the same is not being claimed to be used in animals as a therapeutic drug rather it is a substance to enhance mild production, acting on female organ of the dairy cows which is again illegal as per the Prevention of Cruelty of Animals Act, 1890. In short, rBST registration and renewal or its legal use in the country is neither covered by the spirit of the DRAP Act, 2012 nor does it is permissible as per the law of the land. In this very backdrop, India has not given permission of rBST usage despite holding of controlled trials in 1989, 2004 and 2010.C. THE PUNJAB PURE FOOD RULES, 2007 defines the milk as the normal, clean and pure secretion obtained from the memory glands of a healthy cow, buffalo, goat or sheep and mild shall not contain any . Traces of antibiotic substance and hormonal residue. This definition needs to be evaluated on the ground that 96% milk is consumed unprocessed in Pakistan.d. Against the cautions of withdrawal period of 72 hours for milk and 7 days for the consumption of meat both the companies miserably failed to present any data or document to negate that the puss cells, antibiotic residues, hormone filled milk and meat are not being complied or cannot be complied with in Pakistan.3. THE ETHICAL FRAMEWORKa.CEO is influenced the Registration Board in favour of the rBST and on objection raised by Secretary Livestock & Dairy Deveoplment Department Punjab assured that the very observation pointed out shall be incorporated into the minutes of the meeting but no such thing reflected in the report submitted in the Honourable Court.b. Out of four International Experts of the ICI & Ghazi Brothers, as introduced in the Report of DRAP, three advocating the use of use of rBST in their own countries i.e. Australia, New Zealand and UK. c. The Conflict of Interest as defined under Section 18 of DRAP Act, 2012- Ex-Animal Husbandry Commissioner Dr. Usmani who gave the renewal was representing the company under the guise of employee but in fact associate. On the presentation of the orginal record of the so called research at Bahadarnagar and Pattoki, he was flabbergasted as the mis-interpretation of the actual data was exposed.VIEW POINT OF THE LIVESTOCK & DAIRY DEVELOPMENT DEPARTMENT1. The Legal Aspecta. The Registration Board of DRAP lacks jurisadiction to deal with the registration/ renewal of rBST as it is not a Therapeutic drug.b. The DRAP or the companies never moved the Punjab Government to change and amend the pure Food and Prevention of Animals Cruetly Act, which bars the usage of such like hormones for milk production. The wisdom of the law makers of above said laws deserve our gratitude, having provided a steel shield to the generations from unscrupulous elements.2. THE LOGICAL FRAMEWORK- Situation on ground -the bare reality the Punjab Government envisages:- a. The First ever Livestock and Dairy Development Policy of 2015 of the Punjab Government envisages:-1. Paradigm Shift of L&DD Department from Curative to Preventive Regime of Livestock Sector Government transformation its role from Provincial Disease Attendant to Provincial Livestock Asset Manager. Accordingly, the first ever Mass Vaccination of animals and rural birds and Cross Sectional Survey of preventable diseases in the Punjab from village level was conducted with following:1. The shocking revelation of 60% less animal found on ground as they should have been as per the 2006 Census; one of the major causes for the shrinking of the livestock can safely be attributed to the indiscriminate use of hormones both Injectable and powder form to the animals. The corporate farming has already suffered irreparable loss due to the induced usage of the subject hormones during the last 6-8 years. This revelation perhaps forced the Department and the Government to create the largest database, covering over 2.9 million livestock farmers in the Punjab so far to devise a monitoring and support mechanism. This paramount effort is in response to the SOS call and alarms generated by the poor breeders and consumers of Livestock products.b. THE PUBLIC INTEREST is attached with the consumption of milk and meat. The peri- urban areas of cities have the largest concentration of mich animals and remained victims to sue this hormone as they were lured through marketing gimmickries as proved and warned by the company itself, the ultimate result was higher mastitis, more puss anti-biotic residues and hormones in the produced and offered milk. This unprocessed fresh milk ultimately consumed as such by the urban population with the outcome of wide spread of diseases with raised resistance level to ani-biotic and other increasing complication physical disorders.c. THE SECTOR DEVELOPMENT 1. The Dairy Sector suffered an irreparable loss as the best producing animals wre subjected to the use of rBST. The mortality of calves, weight loss, and increase in calving period and decrease in conception rate added with reproductive disorders played havoc to the best milch animals. The evaporated milch animal head population requires long restoration efforts.The foregoing facts, which form basis of the issue, should have acquired major importance of the proceedings at DRAP, but they, unfortunately, remained neglected. The Punjab Government, being the major stakeholder, as it has largest number of buffalo and cattle population; chief supplier of milch and slaughtering animals to other Provinces and even beyond; largest contributor in the production of mild and sacrificial animals, apprehends that the SOS call of this sector has not received a requisite matching response, which may culminate into devasting effects on the sustainable production capacity of the sector. In view of the above proved facts, the Livestock Department Punjab is of the firm view That:A. The DRAP lacks jurisdiction for approval or renewal of the hormones, including the Fish Powder. The laws of the land do not empower any such forum to allow the use of said products, which are NON-THEERAPEUTIC BY ALL DEFINITIONS;B. None else except the Legislature has the powers to amend the applicable provisions of Pure Food Laws and the Prevention of Animals Cruelty Act. The definition, composition of milk and administering of hormones for milk production will have to be changed prior to allowing the use of such substances which are controversial world over.C. The regime allowing use of any such substance will have to first ensue 100% processing of the milk before its consumption like the US. The country like Pakistan consuming about 96% unprocessed milk and 100% beef from milch animals would require guarantees for meeting minimum standard applications as are observed in the EU and the US and other countries. The Lust of some companies for sale of hormones on one side and antibiotics for the treatment of animals and human beings requires quantification and comprehension in its real context Emerging Zoonotic disease, their wide spread demonstration, the thinning strength of cattle head are nothing but the alarms generated by the nature. This Department humbly submits to the DRAP authorities and the Honourable Court for reflection of the actual stance of the Department. The Honourable Members of the DRAP should be exposed to the developed scenario, enabling them to see through the conspiracy with better understanding of the jurisdictional constraints as envisaged by the law of the land.

5. Presentation of the Secretary (L&DD), Punjab is placed before the board for point wise discussion/ review and evaluation. Other stakeholders have also been invited for the meeting for their point of view.Matter is placed before the Board for a decision.

Case No.02:PANEL INSPECTION OF M/S. PAKCURE PHARMA, RAWATThe case of the company for the registration of Allergy vaccines was discussed in 242nd Meeting of Registration Board. The Registration Board constituted following panel for the product specific inspection of the firm.

1. Gen (R) Karamat A Karamat (Member Registration Board)

2. Brig (R) Muzammil H Najmi (Member Registration Board)

3. Dr. Muhammad Arshad (Member Registration Board)

4. A.Q. Javed Iqbal (Ex. Director QA/LT)

5. Shaikh Ansar Ahmed Director Biological Drugs

The panel inspected the firm twice but the firm was found deficient of the facilities required for the products for which registration is applied. The Board advised for re-inspection of the firm. The FID coordinated for the inspection and has reported as under; One of the member of the panel A.Q. Javed Iqbal has been transferred from the position of Director QA/LT. Gen. (R) Karamat A Karamat has proceeded abroad and not available for inspection. Dr. Muhammad Arshad has refused to join for inspection till the panel is complete. Brig. (R) Muzammil H. Najmi has also refused for inspection till panel is complete. Shaik Ansar Ahmad showed his consent for the inspection.

The firm has requested to conduct their inspection as early as possible. Matter is placed before the Board.

Case No.03: PENDING CASE OF M/s. HI-TECH PHARMACEUTICALS LAHORE FOR POULVAC SE VACCINE

The following case of the firm was discussed in 241st , 246th and 249th Meeting of Registration Board.

Sl.#ApplicantName and SpecsECBDCommittee RecommendationDecision

1.M/s Hi-Tech Pharmaceutical, LahoreManufactured by: M/s Pfizer Animal Health (Pfizer Inc), 2000 Rockford Road, Charles City, Iova, USA Poulvac SE VaccineEach 0.3ml dose contains: -Salmonella enteritidis Phase Type 4.RP> 1.0/dose at release. Salmoella enteritidis Phase Type 8RP.>1.0/dose at release.Salmonella enteritidis Phase Type 13aRP> 1.0/dose at release 37% Formaldehyde.Solution..0.0006mlWhite oil.0.1995mlArlacel-830.1105mlTween-800.001105ml Saline.q.s to 0.3ml(For Veterinary Use)RecommendedMore data is requiredDeferred for clarification from the application regarding use of formalin concentration and review by already constituted committee and veterinary expert of ECBD.

The Registration Board in its 249th Meeting decided as under;

Registration Board decided to take the opinion from further two experts,namely Prof. Dr. Zafar Qureshi, U.V.A.S., Lahore and Prof. Dr. MasoodRabbani U.V.A.S., Lahore.

The expert Prof. Dr. Zafar Queshi did not exist and letter returned from the UVAS, Lahore. Matte was placed before the Director Biologicals who approved the expert namely Prof. Dr. Khushi Mohammad for expert opinion. The details are summarized as below;

Name and designation of ExpertExpert Opinion

Prof. Dr. Masood RabbaniDirector/ ChairmanDepartment of Microbiology, UVAS, LahoreThe letter was reviewed critically and literature related to vaccine. I have no technical observation as Poulvac SE vaccine is a killed vaccine. So in my opinion the product may be registered.

Prof. Dr. Khushi MuhammadDean FVS, UVAS, LahoreI have critically gone through the literature supplied to me with application on subject matter, clarification of Hi-Tech Pharmaceutical Lahore of application which indicates that dose of vaccine is 0.3ml. As per this dose and dossier and dossier of the vaccine, final concentration of formaldehyde (37%) in the culture is 0.2% that is sufficient to inactivate the bacteria. Other component of the vaccine are also according to international standards. The Poulvac SE vaccine may be registered.

Further, the firm has also filed an application with request that the name of manufacturer has been changed from Pfizer Animal Health Lowa, USA to Zoetis Inc. Lowa, USA along with Certificate of Licensing and Inspection from U.S. Department of Agriculture Animal and Plant Health Inspection Service, USA.The case is placed before the Board for a decision.

Case No. 04PENDING CASE OF M/s. POPULAR INTERNATIONAL, KARACHI FROM 240TH MEETING OF REGISTRATION BOARD.

The following case of the firm M/s. Popular International, Karachi was considered in 240th Meeting of Registration Board.S. No.ApplicantBrand name and CompositionDemanded Price4th ECBD RecommendationDecision of the Registration Board.

7.PopularInternational (Pvt)Ltd., Karachi.M/s. Kedrion S.p.ALoc. Ai Conti,CastelvecchioPascoli-Barga (LU),Italy.Uman AlbuminSolution for Infusion250g/1-50ml vialEach 50ml vialcontains:-Human PlasmaProteins containing atleast 95%Albumin.12.5g(Plasma ProteinSolutions (Human)Rs.5,775/Per vial50mlRecommended basedupon the approvalprocess adopted bythe respective SRA of the country of origin.Application date:20.08.2011Deferred forclarification ofconfirmation of similarformulation inPakistan

8.Popular International(Pvt) Ltd., Karachi.M/s. Kedrion S.p.ALoc. Ai Conti,CastelvecchioPascoli-Barga (LU),Italy.Uman AlbuminSolution for Infusion200g/1-100ml vialEach 100ml vialcontains:-Human PlasmaProteins containing atleast 95%Albumin.20g(Plasma ProteinSolutions (Human).Rs.9,450/Per vial100mlRecommended basedupon the approvalprocess adopted bythe respective SRA of the country of origin.Application date:20.08.2011Deferred forclarification ofconfirmation of similarformulation inPakistan.

The firm was advised to provide the evidence of similar formulation in Pakistan. The firm has informed that the following similar formulation are available;

Reg. No.Name of ProductName of ImporterRemarks

007967Plasbumin20ml50ml100ml (Old Registration letter, composition not mentioned)The firm provided pack having the composition of 25 % human albumin.Popular International, Karachi.Exact comparison is not possible based on the information provided.

023674Human Albumin 20% Behring100ml vial containing at least 95% Human Albumin Hakimsons, KarachiHuman albumin is at least 95% and the firm M/s. Popular has specification is of at least 95%

020652Albutein 20% containing at least 95% human albumin100ml vialBiotechna, Karachi Human albumin is same as M/s. Popular specification of 95%.

The case is placed before the Board for a decision.

Case NO. 05PENDING CASE OF M/s. HIVET ANIMAL BUSINESS, LAHORE

The following case of the firm was discussed in 249th Meeting of Registration Board.

S.No.Name of applicant and name of exporterName o f drug and its compositionDate of applicationApplication form and FeePack sizeShelf life

5.Hivet Animal Health Business LahoreInvestigacion Aplicada S.A. de C.V. Puebla Mexico.Emulmax NDEach dose contains:- Newcastle disease inactivated virus La Sota strain Minimum titer before inactivate is 109.0 DIE50/ml11.07.2013Form 5 ARs. 100,000500ml bottle24Months

6.Hivet Animal Health Business LahoreInvestigacion Aplicada S.A. de C.V. Puebla Mexico.Biovac NDEach dose contains:- Newcastle disease inactivated virus La Sota strain Minimum titer before inactivated is 108.0 DEP/ml11.07.2013Form 5 ARs. 100,0001000 doses and 10000 doses bottle24Months

The Board deferred the case for scrutinization of registration dossier and CoPP for confirmation of license holder, manufacturing and release site.

The dossiers were re-checked and as per GMP certificate (Legalized and Notarized by Embassy of Pakistan in Mexico) issued by the Health, Safety and Agro Food Quality National Service, Directorate General of Animal Health (SAGARPA), Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food Mexico the firm M/s. Aplicada S.A. de C.V. Puebla Mexico is GMP compliant as per their requirements. Free sale certificate issued by SAGARPA shows the products Emulmax ND and Biovac ND are on free sale in the country of origin. Further, the composition of above products has also been verified from provided documents.

The case is placed before the Board for a decision. Case No. 06 CASE OF M/s. GRATON PHARMA, KARACHI FOR THE REGISTRATION OF INTERFERON ALFA 2B 3000IU /VIAL (LIPHERON FROM BEIJING SHANGLU, CHINA)

The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration of Interferon Alfa 2b 300MIU injections 22.6. 2011 but their application has not been considered in any meeting till date .The firm has provided evidence of documents and fee challans submitted by them. The case of the firm belongs to pre devolution at the time to Drugs Control Organization, Ministry of Health. The section tried to retrieve the application from old record but still the record is not found. Copy of GMP shows its validity till 14.03.2015. Copy of CoPP has also been provided by the company.

The matter is placed before the Board for a decision.

Item No.III:Cases referred by Pharmaceutical Evaluation & Registration Division.

A. RRR DivisionCase No. 01:Renewal of Fakma PharmaThe name of M/s. Fakma Pharma, Lahore was changed from M/s. Fakma Pharma, Lahore to M/s. Pharmawise Labs (Pvt.) Ltd; Lahore in year 2000 on their request. Subsequently, the firm requested that either change all registration letters with new name of their firm or issue a letter to reflect the said change in each of the registration letter, however, they did not deposit any fee for this purpose. The case was placed before the registration Board in 164th meeting of held on 30-7-2001 wherein Registration Board had decided the case as under).The request of the firm was not acceded to and the was directed to deposit the requisite fee of Rs. 8000/- for each product for transfer of registration in the new nameIt is submitted that as per practice in vogue, in case a firm changes their name/ title, such a firm apply for transfer of registration form previous name to new name with full registration fee. However, the owner of the firm has the view that there is no provision in law for transfer of registration with full fee on same premises. Further, the firm is also of the opinion that the change of the name of company from M/s. Fakma Pharma, Lahore to M/s. Pharmawise labs (Pvt) Ltd: Lahore on Drug Manufacturing License is deemed to be valid for all purposes contingent to their Drug Manufacturing License. The above position was presented before registration board in its 246th meeting held on 10-11th December, 2014 for guidance/ orders in the matter. Registration Board decided to seek opinion of Legal Affairs, Division, DRAP in the matter.The opinion of legal division is as under:-Facts of the case of M/s. Breez PharmaICI were different the facts of the case of M/s. Pharmawise therefore, the two cases are not be taken on the same analogy and equated. M/s. Pharmawise had the right of appeal under Section 9 of Drug Act, 1976 against the decision of the Registration Board. This end needs to be checked. If the firm did not fiel any appeal, the decision of the Registration Board is deemed to have achieved finally. Advise of the Law Division to make the repective ruels explicit and clear may be proceeded. In the meanwhile the Registration Board may decide the matter per applied rules.Advise of the Law Division to make the respective rules exploit and clear may be proceeded. In the meanwhile the registration Board may decide the matter as per applied rules. Case was considered in 251st Registration Board meeting with advise to present all relevant record in forthcoming meeting. Submitted for consideration of Registration Board.Case No. 02: Applications for Re-Registration of drugsFollowing firms have applied for re-registration of drug as they failed to apply for renewal of registration within due time. The cases of M/s. Ambrosia, Woodward Karachi and M/s. Macter International Karachi were deferred in 246th meeting for comments from stake holders in such cases:-M/s. Ambrosia Pharmaceuticals, Islamabad

S. No.Reg. No.Name of Drugs with compositionDate of Initial Reg.Renewal Application Due Date Application Receiving Date for Re-Reg.Documents Provided by the firm

1.035357Ambrocillin 250mg TabletsEach tablets contains:-Amoxicillin (as Trihydrate).250mg18-12-200417-12-200917-10-2012(i). Form-5(ii). Initial Reg. Letter(iii). CRF NOC(iv). Fee Rs.20,000/-

2.035358Ambrocillin 500mg TabletsEach tablets contains:-Amoxicillin (as Trihydrate).500mg-do--do--do--do-

3.041411Micozole N OintmentContains:-Miconazole Nitrate2%04-10-200503-10-2010-do--do-

4.041412Isozole Vag CreamContains:-Isoconazole Nitrate..1%-do--do--do--do-

5.041414Sexatin N CreamEach gm cream contains:-Bufexamac50mgNeomycin Sulphate.2500IUNystatin100,000IU-do--do--do--do-

6.042917Monorate OintmentContains:-Mometasone Furoate.0.1% w/w-do--do-

M/s.Woodward Pakistan (Privat) LTD., Karachi.

S. No.Reg. No.Name of Drugs with compositionDate of Initial Reg.Renewal Application Due Date Application Receiving Date for Re-Reg.Documents Provided by the firm

1.055717Bactizith 500mg CapsuleEach capsule contains:-Azithromycin (as Dihydrate)..500mg(USP Specification)07-04-200906-04-201424-06-2014(i). Initial Reg. Letter (ii). Fee Rs.20,000/-

M/s Macter International Limited Karachi

S.NoRegNo.Name of Drugs with compositionDate of initial registrationRenrewal Application due dateApplication reveiving date for Re-registrationDoucments provided by the firm

1000483Genticyn HC Cream Each gm contains:-Gentamicin Sulphate Hydrocotisone Acetate 6.09.200605-9-201124-11-2014(i).Form-5 (ii). InitialReg.letter(iii) CRF NOC(IV) FeeRs. 20,000/-

2010186Genticyn B Cream Each gm contains:-Gentamicin Sulphate.Betamethasone Valerate

dododoDo

3007701Multigesic Cream Each gm contains Diethylamine SalicylatedododoDo

4000497Genticyn Cream Each gm contains Gentamicin Sulphatedodododo

M/s Rakaposhi Pharmaceuticals Pvt Limited Peshawar

The firm has applied for registration of drug as they failed to apply for renewal of registration within due time.

154681Prozam 0.5 mg Tab30.12.200830.12.20137-8-2015(i).Form-5 (ii). InitialReg.letter(iii) CRF

(IV) FeeRs. 20,000

254682Pocin 25 mg TabdododoDo

354679Buper 0.2 mg TabdododoDo

424218Rixcime 400 mg Cap12-3-200212-3-2012doDo

530303Quell 500 mg Tab25-4-200325-4-2013doDo

630304Acumen 250 mg TabdododoDo

732308Rakacid Dry susp 60 ml6-3-20046-3-2014doDo

824217Urti- Care Tab 12-3-200212-3-2012doDo

930305Acumen 500 mg Tab25-4-200325-4-2013doDo

1021642Roxidin 20 mg Tab20-5-199820-5-2013 doDo

1130301Rixcime Dry Susp 30 ml25-4-200325 4- 2013doDo

1233973Deasma Susp 60 ml16 9 - 200416 9 - 2014doDo

1332305Kavaflox 500 mg tab6-3-20046-3-2014doDo

1432792Rothin Dry Powder 15 ml/ 12-6-200412-6-2014 doDo

1532798Coxban 200 mg CapdododoDo

1633968Klebro Susp 16-9-200416-9-2014doDo

1732377Zoromed 250 mg Cap3-8-20043-8-2014doDo

1823013H2bf 40 mg Tab20-11-199920-11-2014doDo

1932304Kavaflox 250 mg tab6-3-20046-3-2014doDo

2032302Quell 250 mg tabdododoDo

2132307Rakacid Dry Powder 25 mldododoDo

2233969Rakazine Syp 60/ml16-9-200416-9-2014doDo

2332303Lozamep 20 mg Cap24-3-200424-3-2014doDo

2432791Rothin 250 mg Cap12-6-200412-6-2014 doDo

2523014Dectil 50mh Tab20-11-199920-11-2014doDo

2632800Dompitillium 10 mg Tab12-6-200412-6-2014doDo

2723012H2 BF 20 mg tab20-11-199920-11-2014doDo

2833775Dompitillium Susp 4-9-20044-9-2014doDo

2924218Alert 20 mg Cap12-3-200212-3-2012doDo

30000178-ExPP Zole 20 mg Cap11-5-200411-5-2014doDo

3156325Mudine 2 mg tab21-3-200921-3-2014doDo

3249227Ostamed 70 mg tab3-6-20083-6-2013doDo

3334691Atastan 10 mg tab30-11-200430-11-2014doDo

3458324Rapezol 20 mg tab21-3-200421-3-2014doDo

3523267Ostamed 10 mg tab20-12-200420-12-2014doDo

3649228Esorok 20 mg Cap3-6-20083-6-2013doDo

3754673Xcite 10 mg tab30-12-200830-12-2013doDo

3835628Lomexin 200 mg tab20-12-200420-12-2014doDo

3949500Malamether Plus tab17-7-200817-7-2013doDo

4032376Rakalide 100 mg tab3-8-20043-8-201410-8-2015Do

4130306Acumen Dry Susp 30 ml25-4-200325-4-2013doDo

4232802Mebamine 500 mcg tab12-6-200412-6-2014doDo

4332306Rakazole 40 mg tab6-3-20046-3-2014doDo

4432583Vifolix Cap 25-6-200425-6-2014doDo

45001137ExRakaflex 500 mgCap29-12-200829-12-2013doDo

4632375Rakaprofen 100 mg tab3-8-20043-8-2014doDo

4733972Rakamizole Susp 60 ml16-9-200416-9-2014doDo

4856326Roxbex 20 mg tab21-3-200921-3-2014doDo

4932310Rakacid 500 mg tab6-3-20046-3-2014doDo

5032309Rakacid 250 mg tabdododoDo

5132790Rakazine 10 mg tab12-6-200412-6-2014doDo

5254680Sonaril 3 mg tab30-12-200830-12-2013doDo

5335627Moxacin 400 mg tab20-12-2004 20-12-2014doDo

5432793Leucon Dry susp 50 mg12-6-200412-6-2014doDo

5532794Leucon Cap 150 mg dododoDo

5632796Kilbac 125 mg SuspdododoDo

5732797Kilbac 250 mg SuspdododoDo

Submitted for consideration of Registration Board.

Case No.03:M/s Cherry Pharmaceuticals International, Lahore has applied for renewal of drug registration with following details:-S.No.Reg.NoName of Drugs withInitialDate of Reg Validity of Registration

1020109Anticoc super powder1-12-1997(transferred to Ms/Cherry on 17-8-2009 16-8-2014

2043112Milicoli Oral Solution24-4-200623-4-2011-do--do-

3044924Antitox Water Soluble Powder25-1-200724-1-2012-do--do-

The firm has applied on 5-10-2011 for the change of manufacturers Name from M/s Franvet, France to M/s Qalian, France. Approval to the request of firm was granted on 30-1-2013. Submitted for the consideration of the Registration BoardB. Pharmaceutical Evaluation CellCase No.01: Applications for registration of new molecules (Evaluator: In-charge Evaluation Cell)a. Imported.S/NName and address of manufacturer / ApplicantBrand Name(Proprietary name + Dosage Form + Strength)

Composition

Pharmacological Group

Finished product SpecificationType of Form

Initial date, diary

Fee including differential fee

Demanded Price / Pack sizeRemarks on the formulation (if any) including International status in stringent drug regulatory agencies / authorities

Me-too status

GMP status as depicted in latest inspection report (with date) by the EvaluatorRemarks by Evaluator

1. M/s Novartis Pharma (Pakistan) Limited, 15 West Wharf P.O Box 100 Karachi. Novartis Pharma Stein AG, Stien, Switzerland.Ultibro BreezhalerEach Capsule contains:Indacaterol 110mcg and Glycopyrronium 50mcg (143 microgram glycopyrrnium bromide equivalent to 110 micrograms glycopyrrnium)

(Bronchodilator)Form-5 (A)

Dy. No: 84 dated 22-01-2014

100,000/- dated 22-01-201430s Rs.6,424/- Ultibro Breezhaler Novartis Europharm Limited. EMA COPP was issued on 23-01-2015

2. M/s AGP (Private) Limited. B-23 S.I.T.E Karachi.

LTS Lohmann Therapie-System AG, Lohmannstr 2,D-56626 Andernach, GermanyNeupro 2mg/24hrEach patch of 10cm2 contains 4.5mg Rotigotine (UCB Specs)(Antiepileptic)Form-5 (A)

Dy. No: 386 dated 19-05-2014

100,000/- dated 19-05-201428s Rs.7,115/- Neupro UCB INC COPP is issued on dated: 30-08-2013Storage conditions are not as per innovator. Pharmacological group wrongly mentioned. Sole Agency Agreement with complete contact detail of exporter.



Dy. No: 387 dated 19-05-2014

100,000/- dated 19-05-201428s Rs.14,225/- Neupro UCB INCCOPP is issued on dated: 30-08-2013Storage conditions are not as per innovator. Pharmacological group wrongly mentioned. Sole Agency Agreement with complete contact detail of exporter.



Dy. No: 384 dated 19-05-2014

100,000/- dated 19-05-201428s Rs.21,340/- Neupro UCB INCCOPP is issued on dated: 30-08-2013Storage conditions are not as per innovator. Pharmacological group wrongly mentioned. Sole Agency Agreement with complete contact detail of exporter.



Dy. No: 380 dated 19-05-2014

100,000/- dated 19-05-201428s Rs.28,450/- Neupro UCB INC COPP is issued on dated: 30-08-2013Storage conditions are not as per innovator. Pharmacological group wrongly mentioned. Sole Agency Agreement with complete contact detail of exporter.


M/s Aesica Pharmaceutical GmbH Galileistrasse 6 08056Zwickau Germany.Vimpat film coated tablet 150mgTabletEach film coated tablet contains: Lacosamide.150mg (UCB specs)(Antiepileptic)Form-5 (A)

Dy. No: 131 dated 20-09-2013

100,000/- dated 20-09-201356s Rs.40,230/- Vimpat UCB INC FDA50mg, 100mg, 150mg, 200mg

Lacolep by Hilton Pharma Karachi.

The product is locally registered in 50mg, 100mg, 150mg and 200mg.COPP was issued on 22-11-2012 GMP was issued on 27-11-2012



Dy. No: 133 dated 20-09-2013

100,000/- dated 20-09-201314s Rs.3,352/- Vimpat UCB INC FDA50mg, 100mg, 150mg, 200mg





Dy. No: 128 dated 20-09-2013100,000/- dated 20-09-201356s Rs.26,820/- Vimpat UCB INC FDA50mg, 100mg, 150mg, 200mg





Dy. No: 132 dated 20-09-2013100,000/- dated 20-09-201356s Rs.53,640/- Vimpat UCB INC FDA50mg, 100mg, 150mg, 200mg




M/s UCB Manufacturing Inc. 331 Clay Road (755 Jefferson Road) Rochester, NY 14623 USA Vimpat Syrup 10mg/mlSyrupEach ml contains: Lacosamide.10mg (UCB specs)(Antiepileptic)Form-5 (A)

Dy. No: 129 dated 20-09-2013100,000/- dated 20-09-2013200ml Rs.14,268/- Vimpat UCB INC 10mg/ml oral solutionCOPP was issued on dated. 22-11-2011 by European Medicines Agency


M/s UCB Pharma SA Chemin du foriest B 1420 Braine-Alleud Belgium Vimpat 10mg/ml solution for infusionInfusionEach ml of solution contains: Lacosamide.10mg (UCB specs)(Antiepileptic)Form-5 (A)

Dy. No: 130 dated 20-09-2013100,000/- dated 20-09-201320ml Rs.10,818/- Vimpat UCB INC 10mg/ml IV infusionPhotocopy of COPP dated. 22-11-2012

12. M/s Pfizer Pakistan Limited, 12 Dockyard Road, West Wharf, Karachi.

Pfizer Manufacturing Deutschland GmbH Betriebsstatte Freiburg Mooswaldallee 179090 Freiburg Germany.XeljanzTabletEach tablet contains:Tofacitinib.5mg(Factor Xa Inhibitor)Form-5 (A)

Dy. No: 170 dated 27-09-2013

50,000/- dated 27-09-2013Not mentioned. Xeljanz by PF Prism CBStorage conditions are not as per innovator.COPP is issued by Swissmedic and does not provide information of manufacturing / packaging to be done at USA.Label shows the product is manufactured in Ireland while as per application it is manufactured at Germany and USA.Last Inspection Report conducted by the concerned Regulatory Authority for manufacturing process at USA.

13. M/s Pfizer Pakistan Limited, 12 Dockyard Road, West Wharf, Karachi.

Pfizer Manufacturing Deutschland GmbH Betriebsstatte Freiburg Mooswaldallee 179090 Freiburg Germany.XeljanzTabletEach tablet contains:Tofacitinib.10mg(Factor Xa Inhibitor)Form-5 (A)

Dy. No: 169 dated 27-09-2013

50,000/- dated 27-09-2013Not mentioned. Xeljanz 10mg is not FDA approved. Storage condition is not as per innovator.COPP is issued by Swissmedic and does not provide information of manufacturing / packaging to be done at USA.Label shows the product is manufactured in Ireland while as per application it is manufactured at Germany and USA.Last Inspection Report conducted by the concerned Regulatory Authority for manufacturing process at USA.

14. M/s Bayer Pakistan (Pvt.) Limited.

M/s Bayer Pharma AG 51368 Leverkusen Germany.Stivarga (Regorafenib) 40mg film coated tablets.Film coated tablets.Each film coated tablet contains.Regorafenib40mg(Regorafenib is a protein kinase inhibitor with the ATC code L01XE21.)Form-5 (A)Dy. No: 370 dated 03-12-201350,000/- dated 03-12-2013To be submitted latter. GMP inspection conducted December 14 to 16, 2010 by German Authority.

Certificate of medicinal product dated 18-09-2013 issued by EMA is provided.

15. M/s Abbott Laboratories, Karachi.

M/s Ferrer Internacional. S.A. Joan Buscalla 1-9 08173-Sant Cugat del Valles (Barcelona) SpainNucleo CMP Forte Capsules.Capsules.Each Capsule contains.Cytidine5mgUridine..1.33mg(Musculoskeletal System)Form-5 DDy. No: 314 dated 11-11-201350,000/- dated 11-11-2013To be forwarded.GMP issued on February 09-2011, by Spanish GovernmentCOPP issued on 07-19-2013.Stability studies conducted at 30C / 60%

16. M/s Sanofi- eventis Pakistan Limited. Plot No.23, Sector No.22, Korangi Industrial Area s Plot No.23, Sector No.22, Korangi Industrial Area Karachi.M/s Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst 65926 Frankfurt am Main GermanyLyxumia.Solution of injection.Each dose of 0.2 ml contains.Lixisenatide20mg(ATC code: A10BX10)Form-5 ADy. No: 763 dated 28-06-2013100,000/- dated 28-06-20131s/ Rs.7506.8Lyxumia (Sanofi Aventis EMA approved)FDA approval is delayed sighting internal data from cardiovascular risks study.

17. M/s Sanofi- eventis Pakistan Limited. Plot No.23, Sector No.22, Korangi Industrial Area s Plot No.23, Sector No.22, Korangi Industrial Area Karachi.

M/s Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst 65926 Frankfurt am Main GermanyLyxumia.Solution of injection.Each dose of 0.2 ml contains.Lixisenatide10mg(ATC code: A10BX10)Form-5 ADy. No: 761 dated 28-06-2013100,000/- dated 28-06-20131s/ Rs.7506.8Lyxumia (Sanofi Aventis EMA approved)FDA approval is delayed sighting internal data from cardiovascular risks study.

18. M/s Sanofi- eventis Pakistan Limited. Plot No.23, Sector No.22, Korangi Industrial Area s Plot No.23, Sector No.22, Korangi Industrial Area Karachi.

M/s Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst 65926 Frankfurt am Main GermanyLyxumia.Solution of injection.Lyxumia Pen-injector is available in two different dosage strengths: 10g and 20g per 0.2ml administration volume. Body and cap are provided in two different colors: green (10g) and burgundy (20g)(ATC code: A10BX10)Form-5 ADy. No: 762 dated 28-06-2013100,000/- dated 28-06-20131+1=2s/ Rs.15,013.6/-Lyxumia (Sanofi Aventis EMA approved)FDA approval is delayed sighting internal data from cardiovascular risks study.

19. M/s Novartis Pharma (Pakistan) Limited

M/s Sandoz Onco Therapies Limited Plot No. 284, Bommasandra-Jigani Link Road , Industrial Area, AnekalTaluk, Bangalore 560, 105 India.Veltezom 3.5mg/Vial Powder for Solution for Injection.Vial Injectable.Each Vial contains.Brotezomib3.5mg(Antineoplastic agent)Form-5 Dy. No: 296 dated 31-03-201450,000/- dated 25-07-20131s/ Rs.20,317/-Velcade Millennium PharmsCOPP issued on dated. 05-01-2013

b. Local manufactured.S/NName and address of manufacturer / ApplicantBrand Name(Proprietary name + Dosage Form + Strength)

Composition



Initial date, diary



Me-too status

GMP status as depicted in latest inspection report (with date) by the EvaluatorRemarks by Evaluator

20. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Esli 800mg TabletsEach Tablet contains:Eslicarbazepine Acetate.800mg(Anti-epileptic)Form-5-D

Dy. No: 1639 dated 27-08-2013

50,000/- dated 27-08-2013Rs.825/Tab Aptiom 800mg by Sunovion Pharms INC (FDA)Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

21. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Esli 400mg TabletsEach Tablet contains:Eslicarbazepine Acetate.400mg

(Anti-epileptic)Form-5-D

Dy. No: 1637 dated 27-08-2013

50,000/- dated 27-08-201310s,20s,30sRs.6,000/-Rs.12,000/-Rs.18,000/-Aptiom 400mg by Sunovion Pharms INC (FDA)Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

22. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Esli 200mg TabletsEach Tablet contains:Eslicarbazepine Acetate.200mg

(Anti-epileptic)Form-5-D

Dy. No: 1638 dated 27-08-2013

50,000/- dated 27-08-201310s,20s,30sRs.4,000/-Rs.8,000/-Rs.12,000/- Aptiom 200mg by Sunovion Pharms INC (FDA)Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

23. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Rasidon 120mg Each Tablet contains:Lurasidone HCl..120mg (Antipsychotic)Form-5-D

Dy. No: 139 dated 13-02-201350,000/- dated 13-02-201310s,20s30s Rs.16,000/-Rs.32,000/-Rs.48,000/- Latuda Sunovion Pharm INCStability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.







27. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Canaglu 100mg Tablets Each film coated Tablet contains:Canagliflozin100mg (Anti-Diabetic)Form-5-D

Dy. No: 1585 dated 23-08-201350,000/- dated 23-08-201310s/Rs.6,500/- Invokana FDAStability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

28. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Canaglu 300mg Tablets Each film coated Tablet contains:Canagliflozin300mg (Anti-Diabetic)Form-5-D

Dy. No: 1582 dated 23-08-201350,000/- dated 23-08-201310s/Rs.7,500/- Invokana FDA Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

29. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Dapa 10mg TabletsEach film coated Tablet contains:Dapagliflozin10mg (Anti-Diabetic)Form-5-D

Dy. No: 1584 dated 23-08-201350,000/- dated 23-08-201310s/Rs.7,000/- Farxiga (Astrazeneca ab) 50mg, 10mg FDAStability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

30. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Dapa 5mg TabletsEach film coated Tablet contains:Dapagliflozin5mg (Anti-Diabetic)Form-5-D

Dy. No: 1583 dated 23-08-201350,000/- dated 23-08-201310s/Rs.5,500/- Farxiga (Astrazeneca ab) 50mg, 10mg FDAStability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

31. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Apix 2.5mg TabletsTablet.Each film coated Tablet contains:Apixaban.2.5mg (Anticoagulant)Form-5-D

Dy. No: 400 dated 06-11-201350,000/- dated 06-11-201310s,20s,60sRs.475/tablet- Eliquis 2.5mg, 5mg (BMS) FDAStability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

32. M/s Hilton Pharma (Pvt.) Ltd. 13, Sector 15, Korangi Industrial Area, Karachi.Apix 5mg TabletsTablet.Each film coated Tablet contains:Apixaban.5mg (Anticoagulant)Form-5-D

Dy. No: 102dated 07-02-201450,000/- dated 07-02-201410s,20s,60sRs.516.58/tablet- Eliquis 2.5mg, 5mg (BMS) FDAStability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

33. M/s Getz Pharma, (Private) Limited 29-30/27, Korangi Industrial Area Karachi.Lansodex Capsule 60mgDelayed Release CapsulesEach delayed release contains:Enteric coated pellets of Dexlansoprazole.60mgPPI (Proton Pump Inhibitor)Form-5-D

Dy. No: Not mentioned.dated 19-10-2011Rs.15,000/-dated 30-07-2013Rs. 5,000/-06-08-2015Rs.30,000/-14s/Rs.1680/- Dexlanxilant 30mg, 60mg Takeda Pharms FDA.Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

34. M/s Getz Pharma, (Private) Limited 29-30/27, Korangi Industrial Area Karachi.Lansodex Capsule 30mgDelayed Release CapsulesEach delayed release contains:Enteric coated pellets of Dexlansoprazole.30mgPPI (Proton Pump Inhibitor)Form-5-D

Dy. No: Not mentioned.dated 19-10-2011Rs.15,000/-dated 30-07-2013Rs. 5,000/-06-08-2015Rs.30,000/-14s/Rs.840/- Dexlanxilant 30mg, 60mg Takeda Pharms FDA.Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

35. M/s Getz Pharma, (Private) Limited 29-30/27, Korangi Industrial Area Karachi.PrevirFilm coated tablet.Each film coated tablet contains:Telaprevir750Anti viral (HCV serine protease inhibitors)Form-5-DDy. No: Not mentioned.dated 31-08--201315,000/- Rs.35,000/- dated 30-08-201310s,30s Rs.10,000/-Rs.30,000/- Inspection. 15-12-2010International status not confirmed Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

36. M/s Getz Pharma, (Private) Limited 29-30/27, Korangi Industrial Area Karachi.PrevirFilm coated tablet.Each film coated tablet contains:Telaprevir375Anti viral (HCV serine protease inhibitors)(Getz specs)Form-5-DDy. No: Not mentioned.dated 31-08-201315,000/- Rs.35,000/- dated 30-07-201310s,30s Rs.5,000/-Rs.15,000/- Incivek by Vertex pharmsFDA:375mgInspection. 15-12-2010 Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

37. M/s Searl Company Limited. 1st Floor N.I.C Building Abbasi Shaheed Road Off: Shahrah-E-Faisal Karachi.Dexlans 60mg CapsuleCapsule.Each Capsule contains:Dexlansoprazole..60mg(Anti Ulcerant)

Form-5-DDy. No: Not mentioned.Dated. 08-10-2013Rs.50,000/- 14s,/Rs.15,000/- Dexlanxilant 30mg, 60mg Takeda Pharms FDA.The innovator product is delayed release capsule while firm has not applied it.

38. M/s Searl Company Limited. 1st Floor N.I.C Building Abbasi Shaheed Road Off: Shahrah-E-Faisal Karachi.Dexlans 30mg CapsuleCapsule.Each Capsule contains:Dexlansoprazole..30mg(Anti Ulcerant)

Form-5-DDy. No: Not mentioned.Dated. 08-10-2013.Rs.50,000/- 14s,Rs.880/- Dexlanxilant 30mg, 60mg Takeda Pharms FDA. The innovator product is delayed release capsule while firm has not applied it.

S/NName and address of manufacturer / ApplicantBrand Name

(Proprietary name + Dosage Form + Strength)Composition



Initial date, diary


Demanded Price / Pack sizeInternational status in reference drug agencies / authorities

Me-too status

GMP status as depicted in latest inspection report (with date) by the EvaluatorRemarks

39. M/s Martin Dow Pharmaceuticals (Pak), Limited, Plot 37, Sector 19, Korangi Industrial area, Islamabad.EUGLUCON Plus Tablets

Each film coated tablet contains:Glibenclamide.2.5mgMetformin HCL500mgForm 5

Dy. No: dated 8,000/- dated 12-01-11

12000/- dated 31-07-13

Rs. 70/- per tablet, Pack of 30sGlucovance Tablets of Alphapharm Ltd NSW ( TGA Approved)

Glucomet of Pharmatec

Inspection of M/s Martin Dow Pharma Karachi was carried out on 24-02-15 by the panel of inspectors wherein they unanimously recommended the grant of GMP for export purpose.

40. -do-DUVEL Tablets 25mg

Each film coated tablet contains:Sitagliptin phosphate MDP eq. to Sitagliptin25mg

DPP-4 Inhibitor

Manufacturer Form 5

Dy. No: dated 8,000/- dated 27-01-11

12000/- dated 31-07-13

Rs. 600, 1200, 1800/- pack of 10, 20 ,30sJanuvia of MSD Uk

Sitagen of Ferozsons Lab

41. -do-DUVEL Tablets 50mg


DPP-4 Inhibitor

Manufacturer Form 5

Dy. No: dated 8,000/- dated 27-01-11

12000/- dated 31-07-13



42. -d0-DUVEL Tablets 100mg


DPP-4 Inhibitor

Manufacturer Form 5

Dy. No: dated 8,000/- dated 27-01-11

12000/- dated 31-07-13



43. M/s Don Valley Pharma, 31 Km Ferozpur Road, LahoreEZOLE Capsule

Each capsule contains:Esomeprazole Magnesium 88.8mg equivalent to Esomeprazole20mg

Benzimidazole derivative

Manufacturer

M/s Surge Laboratories, SheikhupuraForm 5

Dy. No: 224 DDCdated 20-01-2011 8,000/- dated 20-01-201112000/- dated 10-03-14

As per brand leader/ Pack of 2x7sNexium of AstraZeneca (USFDA)

Nexum of Getz

Inspection of the firm was carried out on 06-07-15 by the area FID and nothing was reported in violation of GMP. a. Manufacturing method of carboscisteine capsules is submitted. Revised manufacturing method for Esomeprazole capsules need to be submitted.b. GMP certificate of M/s surge laboratories need to be submitted.

44. -do-EZOLE Capsule

Each capsule contains:Esomeprazole Magnesium 88.8mg equivalent to Esomeprazole40mg

Benzimidazole derivative

Manufacturer

M/s Surge Laboratories, SheikhupuraForm 5

Dy. No: 225 DDCdated 20-01-2011 8,000/- dated 20-01-201112000/- dated 10-03-14

As per brand leader/ Pack of 2x7sNexium of AstraZeneca (USFDA)

Nexum of Getz a. Manufacturing method of carboscisteine capsules is submitted. Revised manufacturing method for Esomeprazole capsules need to be submitted.b. GMP certificate of M/s surge laboratories need to be submitted.

45. M/s Gillman Pharmaceuticals, 41/2- Phase I & II, Industrial Estate Hattar.PATHODIME Injection 250mg (I.M)

Each vial contains:Ceftazidime as pentahydrate.250mg

Cephalosporin

USPForm 5

Dy. No: 232dated 24-01-11 8,000/- dated 24-01-11

12000/- dated 20-07-13

As per SRO/ Pack of 1sNot found in reference agencies

Cefcom of Barrett & Hodgson Karachi

Inspection of the firm was carried out on 08-05-15 by the panel of inspectors and nothing was observed in violation to GMP.Evidence of approval of same dosage form and strength is not found in reference drug agencies.

46. -do-PATHODIME Injection 500mg (I.V)

Each vial contains:Ceftazidime as pentahydrate.250mg

Cephalosporin

USPForm 5

Dy. No: 236dated 24-01-11 8,000/- dated 24-01-11

12000/- dated 20-07-13

As per SRO/ Pack of 1sCeftazidime 500 mg Powder for Solution for Injection of Stravencon UK


47. -do-PATHODIME Injection 1g (IV)

Each vial contains:Ceftazidime as pentahydrate.1g

Cephalosporin

USPForm 5

Dy. No: 237dated 24-01-11 8,000/- dated 24-01-11

12000/- dated 20-07-13

As per SRO/ Pack of 1sCeftazidime 1g Powder for solution for injection of Wockhart UK


48. -do-TERBIZOLE Tablet

Each film coated tablet contains:Terbinafine as HCL..125mg

Antifungal

Manufacturer Form 5

Dy. No: 234dated 24-01-11 8,000/- dated 24-01-11

12000/- dated 29-07-13

As per SRO/ Pack of 1x10sNot found in reference agencies

Lamisl of NovartisEvidence of approval of applied dosage form and strength in reference drug agencies is not submitted.

49. -do-APRAZOLE Tablets

Each enteric coated table contains:Pantoprazole sodium sesquihydrate40mg

PPI

USPForm 5

Dy. No: 234dated 24-01-11 8,000/- dated 24-01-11

12000/- dated 29-07-13

As per SRO/ Pack of 14sPantoprazole tablets of Takeda UK

Gastipan of Albro

50. FOLIMAL Tablet

Each tablet contains:Iron III hydroxide Polymaltose Complex eq. to elemental Iron .100mgFolic Acid.0.35ng

Hematinic

Manufacturer

Form 5

Dy. No: 234dated 24-01-11 8,000/- dated 24-01-11

12000/- dated 29-07-13

As per SRO/ Pack of 1x10sNot found/ not provided

Acefer-F of Safron Laboratories

51. -do-GLUCOMAX Tablets

Each film coated tablet contains:Glucosamine sulphate.500mgChondroitin Sulphate.400mg

Glucosaminoglycan

Manufacturer Form 5

Dy. No: 235dated 24-01-11 8,000/- dated 24-01-11

12000/- dated 29-07-13

As per SRO/ Pack of 30sNot found/ Not provided

Artilage tablets of SJ & Ga. Evidence of approval in reference drug agencies is not submitted.b. USP specifications of the finished product are claimed however the same were not found in the official compendia. Copy of the said monograph is required.

52. -do-CALCINATE Tablet

Each tablet contains:Alendronate sodium equivalent to Alendronic acid.70mgCholecalciferol..70mcg

Biphosphonates Vitamin D

ManufacturerForm-5

Dy.No: 230 dated 24-01-11

8000/- dated 24-01-1112000/- dated 29-07-13

As per SRO/Pack of 4sFosavance Tablets of MSD UK

Drate-D of SJ&G Karachi

53. -do-CO-GEN Tablets

Each film coated tablet contains:Codergocrine mesylate..4.5mg Cerebral activator ergot alkaloid

ManufacturerForm-5

Dy.No: 228 dated 24-01-11

8000/- dated 24-01-1112000/- dated 29-07-13

As per SRO/Pack of 10sNot found/ Not provided

Ceregin Tablets of Platinum Pharma KarachiEvidence of approval of same generic, dosage form in reference drug agencies need to be submitted.

54. OSTEO-D-CA Tablets

Each film coated tablet contains:Alfacalcidol0.5mcgCalcium carbonate 1000mg eq. to elemental calcium.400mg

Vitamin D Analogue

Manufacturer Form-5

Dy.No: 227 dated 24-01-11

8000/- dated 24-01-1112000/- dated 29-07-13

As per SRO/Pack of 2x10s3x10sNot found/ Not provided

Oscal-D Tablets of Aeries Pharmaceuticals.a. Evidence of approval of same generic, dosage form and strength in reference drug agencies is not submitted.b. For Alfacalcidol storage instructions are : Under nitrogen, in an airtight container, protected from light, at a temperature of 2 C to 8 C.

55. RECID Tablet 20mgEach enteric coated tablet contains:Rabeprazole sodium20mgPPIManufacturerForm-5Dy.No: 240 dated 24-01-118000/- dated 24-01-1112000/- dated 29-07-13As per SRO/Pack of 14sPariet Tablets of Easai UKAcifix Tablets of Aeries Pharma

56. ALERBI Tablets 10mg

Each tablet contains:Ebastine10mg

Antihistamine

Manufacturer Form-5

Dy.No: 238 dated 24-01-11

8000/- dated 24-01-1112000/- dated 29-07-13

As per SRO/Pack of 10sNot found/ Not provided

Aerius Tablets of Dermagen Pharma

57. M/s Barrett & Hodgson Pakistan (Pvt) Limited, F/423 SITE KarachiBUDECORT Nasal Spray

Each dose contains:Budesonide.32mcg

Anti-inflammatory Synthetic Corticosteroid

Manufacturer Form 5

Dy. No: 2181 R-IIdated 14-12-10 8,000/- dated 10-12-10

Rs. 400/- Pack of 1sRhinocort Aqua of AstraZeneca (USFDA)

Not founda. Manufacturing facility for applied formulation needs confirmation.b. Firm submitted that applied drug is available as inhalers in Pakistan

58. -do-BUDECORT Nasal Spray

Each dose contains:Budesonide.64mcg

Anti-inflammatory Synthetic Corticosteroid

Manufacturer Form 5

Dy. No: 2180 R-IIdated 14-12-10 8,000/- dated 10-12-10

Rs. 400/- Pack of 1sRhinocort Aqua of AstraZeneca (MHRA)

Not founda. Manufacturing facility for applied formulation needs confirmation.b. Firm submitted that applied drug is available as inhalers in Pakistan

59. M/s Remington Pharmaceutical Industries, (Pvt) Limited, 18Km Multan Road, Lahore.AMIOL Tablet

Each film coated tablet contains:Amlodipine besylate eq. to Amlodipine..5mgOlmesartan Medoxomil40mg

CCB/ ARB

ManufacturerDy.No:

8000/- dated 31-12-1012000/- dated 30-07-13

Leader Price./ 2x10sAzor Tablets of Daiichi Sankyo (USFDA)

Omsana AM of Hilton Pharma Karachi.

Panel inspection of the firm was carried out on 10-06-14 and recommended the issuance of GMP.

60. -do-AMIOL Tablet

Each film coated tablet contains:Amlodipine besylate eq. to Amlodipine..10mgOlmesartan Medoxomil20mg

CCB/ ARB

ManufacturerDy.No: 845 dated 31-12-10

8000/- dated 31-12-1012000/- dated 30-07-13

Leader Price./ 2x10sAzor Tablets of Daiichi Sankyo (USFDA)

Omsana AM of Hilton Pharma Karachi.

61. M/s Unexolabs (Pvt) Limited, Fine Chemicals & Pharmaceutical Manufacturers, 95 Km, Sheikhupura Road, LahoreMENTIN-OG Tablets

Each film coated tablet contains:Amoxicillin as Trihydrate..875mgClavulanic acid as potassium salt.125mg

Antibacterial/ Penicillin

Manufacturer Form-5

Dy. No: 10760 dated 23-11-10

8000/- dated 23-11-1012000/- dated 26-07-13

Rs. 250/- Pack of 6s (Blister Pack or Glass bottle loose pack)Co-amoxiclav of Blufish Pharmaceuticals UK (MHRA)

Zamoclav of Zafa Pharmaceuticals Karachi

Panel inspection of the firm was carried out on 16-05-14 wherein the panel recommended the renewal of DML.

62. M/s Asian Continental (Pvt) Limited, D-32, S.I.T.E., II Super Highway, Karachi.SIALIC Tablet 75mg

Each enteric coated tablet contains:Acetyl salicylic acid .75mg

Analgesic, Antipyretic

Form-5

Dy.No: 1033 dated 02-011-10 (DDC-RIII)

8000/- dated 02-11-1012000/- dated 26-02-14

As per latest decision of PRC/3x10sAspirin gastro resistant tablets of Actavis UK (MHRA)

Loprin of Highnoon Pharma Lahore

Inspection of the firm was carried out on 09th Sep 2014 by the area FID and acceptable level of GMP compliance is found

63. M/s Caraway Pharmaceuticals, Plot No.12, Street No.03, National Industrial Zone, Rawat, Islamabad.CARACINE Tablet 0.25mg

Each tablet contains:Hyoscyamine sulphate..0.250mg

Acetylcholine Inhibitor

USPForm-5

Dy.No: 1033 dated 02-011-10 (DDC-RIII)

8000/- dated 02-11-1012000/- dated 26-02-14

As per PRC./ pack of 1x10s2x10s3x10s5x10s10x10s20x10s50x10s100x10sAvailability in SRAs not submitted by the firm

Anapaz tablets of Hilton

Inspection of the firm was carried out on 26-12-14 by the panel and recommends the renewal of DMLEvidence of approval of same generic, dosage form in reference agencies is required.

64. M/s Safe Pharmaceuticals, Karachi PREBALIN Capsule 75mg

Each capsule contains:Pregabalin 75mg

Antiepileptic

Manufacturer Form-5

Dy.No:

8000/- dated 10-05-1012000/- dated 22-05-13

As per PRC

Lyrica Capsules (USFDA)

Lyrica of Pfizer Karachi

Inspection of the firm was carried out on 09-05-15 by the area FID and rated as GOOD.

S/NName and address of manufacturer / ApplicantBrand Name(Proprietary name + Dosage Form + Strength)

Composition



Initial date, diary



Me-too status

GMP status as depicted in latest inspection report (with date) by the Evaluator

Recommendations by the Evaluators

65. M/s Evergreen Pharmaceuticals, 69-70/B Main Glaxo Town, Industrial Estate, Ferozpur Road, Lahore Avinox oral Solution

Each ml contains:Novaminsulfon..40mgEtileferin0.2mgCalcium gluconate.100mgMagnesium gluconate..10mgSodium Salicylate7mgNicotinamide.0.3mgCaffiene .10mgBoric acid..10mg

Supplement to antibiotic (Restorative)

Manufacturer Form-5

Dy No:

20000/- dated 09-10-1340000/- 03-12-13

Decontrolled / 100ml, 250ml, 500ml & 1LNovafas of Intervac

Inspection of the firm was carried out on 17-12-14 by the area FID and GMP is rated as satisfactory

Case No.02:Cases of Pregabalin

S/NName and address of manufacturer / ApplicantBrand Name(Proprietary name + Dosage Form + Strength)

Composition



Initial date, diary



Me-too status

GMP status as depicted in latest inspection report (with date) by the Evaluator

Recommendations by the Evaluators

66. M/s Searle Pakistan Lahore. ALBEN Capsule 75mg

Each capsule contains:Pregabalin75mg

Antiepileptic

Manufacturer Form-5

Dy No:8000/- dated 17-10-0812000/- dated 19-11-14

14.28Rs. per capsule200 Rs. Pack of 14 capsulesLYRICA (USFDA)


GMP certificate issued on 20-08-14

67. -do- ALBEN Capsule 100mg


Antiepileptic

Manufacturer Form-5

Dy No:8000/- dated 17-10-0812000/- dated 19-11-14






Antiepileptic

Manufacturer Form-5

Dy No:8000/- dated 17-10-0812000/- dated 19-11-14

25Rs. per capsule350 Rs. Pack of 14 capsulesLYRICA (USFDA)





Antiepileptic

Manufacturer Form-5

Dy No:8000/- dated 17-10-0812000/- dated 19-11-14




Case No.03:Registration of applications (Routine cases)Evaluator IVS/NName and address of manufacturer / ApplicantBrand Name(Proprietary name + Dosage Form + Strength)CompositionPharmacological GroupFinished product SpecificationType of FormInitial date, diaryFee including differential feeDemanded Price / Pack sizeInternational status in stringent regulatory agencies

Me-too status

GMP status as depicted in inspection report (dated)

Remarks / Observations

70. M/s Remington Pharmaceutical Industries (Pvt.) Ltd, 18-km Multan Road, LahoreValpin H 5/160/12.5 Tablet

Each film coated tablet contains

i. Amlodipine (as Besylate) B.P ..5.0 mgii. Valsartan U.S.P 160.0 mgiii. Hydrochlorothiazide U.S.P 12.5 mg

Calcium Channel Blocker, Angiotensin II Receptor Antagonist & Thiazide Diuretics

Form 5Rs. 8,000 + 12000 = 20,000/- Dy. No. 2161 (02/02/2011) & Dy. No. 9262 (30-07-2013)

Pack of 14s & 28s Blisters Tablets as per Leader PriceFDA approved Tablet Exforge HCT (Novartis)

Tablet Valam-H 5/160/12.5 (CCL)

71. -do-Valpin H 10/160/12.5 Tablet


i. Amlodipine (as Besylate) B.P ..10 mgii. Valsartan U.S.P 160.0 mgiii. Hydrochlorothiazide U.S.P 12.5 mg

Calcium Channel Blocker, Angiotensin II Receptor Antagonist & Thiazide Diuretics

Form 5Rs. 8,000 + 12000 = 20,000/- Dy. No. 2163 (02/02/2011) & Dy. No. 9265 (30-07-2013)

Pack of 14s & 28s Blisters Tablets as per Leader PriceFDA approved Tablet Exforge HCT (Novartis)

Tablet Valam-H 10/160/12.5 (CCL)

72. -do-Valpin 10/320 Tablet


i. Amlodipine (as Besylate) B.P ..10 mgii. Valsartan U.S.P 320.0 mg

Calcium Channel Blocker & Angiotensin II Receptor Antagonist Form 5Rs. 8,000 + 12000 = 20,000/- Dy. No. 2011 (28/01/2011) & Dy. No. 9261 (30-07-2013)

Pack of 14s & 28s Blisters Tablets as per Leader PriceFDA approved Tablet Exforge (Novartis)

Tablet Valsan-AM 10/320 (Hilton)

73. -do-Kiren 150 mg Tablet

Each film coated tablet contains Aliskiren Hemifumerate equivalent to Aliskiren 150mg

Renin Inhibitor

(Manufacture Specification) Form 5Rs. 8,000 + 12000 = 20,000/- Dy. No. 11016 (29/11/2010) & Dy. No. 9299 (30-07-2013)

Pack of 1 x 07s blisterTablets as per Leader PriceFDA approved Tablet Tekturna 150 mg (Novartis)

Tablet Rasilez 150 mg (Novartis)

74. -do-Kiren 300 mg Tablet

Each film coated tablet contains Aliskiren Hemifumerate equivalent to Aliskiren 300 mg

Renin Inhibitor (Manufacture Specification)Form 5Rs. 8,000 + 12000 = 20,000/- Dy. No. 11020 (29/11/2010) & Dy. No. 9297 (30-07-2013)

Pack of 1 x 07s blisterTablets as per Leader PriceFDA approved Tablet Tekturna 300 mg (Novartis)

Tablet Rasilez 300 mg (Novartis)

75. -do-Bestegrel 5 mg Tablet

Each film coated tablet contains Prasugrel Hydrochloride equivalent to Prasugrel 5.0 mg

Renin Inhibitor

(Manufacture Specification)Form 5Rs. 8,000 + 12000 = 20,000/- Dy. No. 2398 (29/11/2010) & Dy. No. 9268 (30-07-2013)

Pack of 14s & 28s Blister Tablets as per Leader PriceFDA approved Tablet Effient 5mg (Elli Lilly)

Tablet Prisa 5 mg (Novartis)

76. -do-Bestegrel 10 mg Tablet

Each film coated tablet contains Prasugrel Hydrochloride equivalent to Prasugrel 10 mg

Renin Inhibitor


Pack of 14s & 28s Blister Tablets as per Leader PriceFDA approved Tablet Effient 10mg (Elli Lilly)

Tablet Prisa 10 mg (Novartis)

77. -do-Nilol 2.5 mg Tablet

Each film coated tablet contains Nebivolol HCl eq to Nebivolol 2.5 mg

Selective Beta Blocking Agent


Pack of 10s & 14s Blister Tablets as per Leader PriceMHRA approved Tablet Nebivolol 2.5 mg (Glenmark)

Tablet Nebil 2.5 mg (Getz)

78. -do-Nilol 5 mg Tablet

Each film coated tablet contains Nebivolol HCl eq to Nebivolol 5 mg

Selective Beta Blocking Agent


Pack of 10s & 14s Blister Tablets as per Leader PriceMHRA approved Tablet Nebivolol 5 mg (Glenmark)

Tablet Nebil 5 mg (Getz)

79. M/s Martin Dow Limited, Plot # 37, Sector 19, Korangi Industrial Area, KarachiLifeline 750 mg Tablet

Each film coated tablet contains Levofloxacin (as Hemihydrate) 750 mg

(USP Specification)

Quinolone Group Antibiotics Form 5Rs. 8,000 + 12000 = 20,000/- Received on 10/02/2011 & 30-07-2013

Unit pack size 10,s / Rs. 500Rs. 50.00 per TabletFDA approved Tablet Levoquin 750 mg (Ortho-McNeil-Janssen Pharmaceuticals)

Tablet Leflox 750 mg (Getz)

GMP compliant vide inspection report dated 24-02-2015

80. -do-Tespral Total Capsules 40 mg + 150 mg

Each Capsule contains:-i. Pantoprazole Sodium Sesquihydrate equivalent to Pantoprazole (Enteric coated) 40 mgii. Itopride (As sustained release pellets) 150 mg

Proton Pump Inhibitor + Prokinetic agent Form 5-DRs. 8,000 + 12000 = 20,000/- Received on 25/06/2011 & 30-07-2013

Unit pack size 10,s / Rs. 946.94

Not provided

i. Source of pellets required.ii. Legalized GMP status of the source required.iii. Stability data of pellets required.iv. International and national availability information required with supported documents.v. Full description of specifications and analytical testing process along with photocopy of authentic references.

81. -do-Viglip Tablet 50 mg

Each Tablet contains:-Vildagliptin 50 mg

DiPeptide Peptidase 4 (DPP-4) inhibitorsForm 5Rs. 8,000 + 12000 = 20,000/- Received on 25/06/2011 & 30-07-2013

Unit pack size 10,s / Rs. 754.30Rs. 75.43 per tablet

TGA approved Tablet Galvus 50 mg (Novartis)

Locally Galvus (Novartis)

i. The innovators brand is not a film coated tablet while firm has claimed their proposed product as film coating tablet.ii. Full description of specifications of active and inactive materials required along with photocopy of authentic references.

82. -do-Neo-Fansidar Tablet 40 + 320 mg

Each Tablet contains:-i. Dihydroartemisinin .. 40 mgii. Piperaquine Phosphate 320 mg

Antiprotozoal & anthelmintic Form 5Rs. 8,000 + 12000 = 20,000/- Received on 04/04/2011 & 31-07-2013

Unit pack size 8s / Rs. 485.00Rs. 61 per tablet

Duo-Cotecxin by Beijing Holley- Cotec Pharmaceuticals Co. Ltd, China

Artequine (Platinum)

i. Full description of specifications and analytical processes required with photocopies of authentic references for further evaluation.

83. M/s Genome Pharmaceuticals (Pvt.) Ltd, 16/1, Phase IV, Industrial Estate, Hattar, HaripurNorella 50 mg Capsule

Each Capsule contains Milnacipran HCl

(Manufacture Spec)

Selective Norepinephrine and serotonin reuptake inhibitor Form 5Rs. 8,000 + 12000 = 20,000/- Received on Dy. 1263 (08-11-2010) &Dy. No. 29 (17/01/2014)

Unit pack 10s as per SRO

Savella in Europe by Forest Pharmaceuticals

Local manufacture not provided.

84. -d0-Asperam 10 mg Chewable Tablet

Each Chewable Tablet contains Escitalopram (as Oxalate) .. 10 mg

(Manufacture Spec)

5HT Reuptake Inhibitor Form 5Rs. 8,000 + 12000 = 20,000/- Received on Dy. 1195 (11-10-2010) &Dy. No. 45 (17/01/2014)

Unit pack 10s as per SRO

Tab Fastoral by CLL Pharma, Europe

Local manufacture not provided.

85. M/s Astellas Pharmaceutical (Pvt.) Ltd, 15-C, Industrial Estate, Hayattabad, PeshawarAstalexim 1.5 gm Injection

Each Vial Contains Cefuroxime Sodium equivalent to Cefuroxime 1.5 gm USP

(USP Spec)

Cephalosporins Form 5Rs. 8,000 + 12000 = 20,000/- Received on Dy. 81 (12-12-2014) &Dy. No. 225 (11/02/2011)

Unit pack 15 ml vial as per SRO

Not Provided

Local manufacture by Lowitt Pharma (MARCEF)

1. Firm needs to provided the dose as IM only or IV only as per international availability.2. Firm has mentioned R.O Water for vial washing while requirement is distilled water for final rinsing of vials.3. Verification of distill water plant required.

86. -do-Astalexim 750 mg Injection

Each Vial Contains Cefuroxime Sodium equivalent to Cefuroxime 750mg USP

(USP Spec)

Cephalosporins Form 5Rs. 8,000 + 12000 = 20,000/- Received on Dy. 228 (12-02-2014) &Dy. No. 167 (11/02/2014)

Unit pack 15 ml vial as per SRO

Not Provided

Local manufacture by Lowitt Pharma (MARCEF)

1. Firm needs to provide the dose as IM only or IV only as per international availab