Tyno SF caseFacts v.s AssumptionsPresented by:Seemal KhalidReko PharmacalPvt. Ltd
• Reko was established in 1962.• Today Reko (ISO-9001-2008 certified)is fully operational with over 150registered products.• Fully operational QC department andQA• HVAC system in all production andstore areas to ensure cGMPstandards.• Inventory management based on SQLsoftware.Company Profile
Liquid Syrup Section Covered area of 2,200 sq. feet Capacity per shift: 40,000 bottles 8 nozzle automatic syrup fillingmachine Automatic labeler
Tyno HistoryExisting formulation Approved formulationEach 5ml contains:Dextromethorphan HBr: 15mgEach 5ml contains:Dextromethorphan HBr:15mgPhenyl propanolamine HCl:10mgChlorpheniramine Maleate:4mgRegistration of Tyno Syrup 30th September 1976Change of formulation 4th August 2001Registration of Tyno-SF 21th April 2011Dextromethorphan HBr:10mgChlorpheniramine Maleate:2mg
Tyno SF cough syrupSafe anti-tussive/cough suppressant.Safe dosage is 5 ml (10 mg) every 5 to 6 hours, (thedose in Tyno- SF) and the maximum dosage should notexceed 20 ml in three divided doses within 24 hours asper instructions on the label.(Reference- Daily Med)64 registered Dextromethorphan containing productsin Pakistan.
Sequence of EventsOn 24th November 2012 media reported that 11 people died inShahdara apparently due to over dosage of a cough syrup.Drug inspectors team and police raided Reko’s distributionoffice SMS and arrested the distributorOn 25th November, at 4.30am police along with the DCOraided the factory premises and shortly afterwards, Provincialdrug inspectors team came to seal the production area of Reko. A case of 302/34 was registered against the ManagingDirector, Khalid Saleem Mian.MD’s house was raided and his driver was taken into custody.
Sequence of EventsThe factory was de-sealed on Tuesday, 27thNovember 2012 when a group of Provincial, CM teamand Federal drug inspectors visited the factorypremises and checked all documentation of Tyno rawmaterial and found them to be in order.The same day, a dozens of media personnel forciblyentered the production areas with the assistance oflocal Drug Inspectors and started recording ignoringwarnings from the factory personnel.
Sequence of Events Press conference on 27th November 2012 in PPMARegional office: Mohammad Zaka presented the actualsituation of Tyno tragedy and requested the Press towait for the DTL reports before broadcasting anyfurther negative news against the manufacturers.LCCI Press Conference on 28th November 2012,President Mr. Farooq Iftikhar said that the incidenthappened only in Shahdara which is a hub of addictsand law enforcement agencies were fully aware of it
Sequence of EventsPPMA Press conference was held in the Press Club on 12th December2012 in which PPMA members were invited. Vice Chairman PPMA pointed certain pertinent facts to the media:1. According to Forensic reports , Tyno was not the cause of deaths in theindividuals.2. The deaths revealed the Punjab government’s inability to address theroot cause of the problem.3. Media was advised not to pass on incorrect information to the publicas this is a technical field and correct scientific facts should bepresented.4. Finally he announced a closure of all pharmaceutical units in thePunjab due to the unfair treatment of the government (whichunfortunately does not happen).
Sequence of EventsOn 24th January 2013, Inspector Shahdara took the following staff membersin their custody for 3 days without any warrant or written instructions.•M.A Ghori, Senior QC Manager•Adnan Mateen, Assistant Import Manager•Syed Naqi Abbas, Assistant Store ManagerOn 6th February 2013, the liquid section was suspended for oneyear which further crippled the company sales as production of 13products was also suspended.MD Khalid Sleem Mian was put on ECL in March upon his returnfrom China after Liver transplant operation.
CDL Report-12th December 2012CDL Report of 12th December declares 4 batches ofTyno to be of “standard” qualityFurthermore active raw materials Dextromethorphanand Chlorphenaramine maleate are also declared to beof standard quality.
Experiment by University of Veterinary &Animal Sciences on Tyno (30th November 2012)Tyno Batch no 5601 was administered to 50 micedivided in 10 groups. The syrup was administered @ dose below, equaland above than the recommended dose. The 10th group was given 64 times the original dose. The mice were observed critically for 89 hours.“During this tenure no death of mice was observed.”
Reports by Punjab Forensic Science AgencyAccording to Forensic Toxicology Preliminary Report releasedon 14-12-2012, the following findings were revealed:1. Out of 12 people whose blood toxicology was determined, 7of them did not have Chrompeniramine Maleate in theirblood which showed that they did not consume TYNO-SF(Dextromethorphan+Chlorpheniramine)2. 5 victims had Dextromethorphan, ChlorphenaramineMaleate with Opiates, Ethanol,Triazolam and Cannabinoidswhich showed that they had combined other narcotics withcough syrup. “Mixing DXM with other depressants can resultin overdose and result in respiratory failure” (Ref: www.healthhoma.com)
Tyno SF Reports?No protocol for detecting Levomethorphan in BP and USPDTL issued its report on finished good TYNO-SF batch # 5601 on 11th Jan2013, which stated that the said batch is declared as Sub-standard on thebasis of Optical rotation. (Reference U.S.P) Whereas there is no such testrecommended for optical rotation in U.S.P. for cough syrups. There is noprotocol for detecting Levomethorphan in BP and USP. Moreover above 200 samples from 30 batches of Tyno SF syrup were taken anddeclared to be of “standard” quality by the DTL.
Long-term repercussions for Reko Reko’s 50 year reputation of being an ethical and quality-conscious hasbeen tarnished by the media and regulatory authorities without following anyproper protocols and investigation procedures. Due to Tyno being one of our highest selling and revenue generatingproduct, we are facing an accumulated loss of Rs 50 million. Currently fighting 4 litigation cases against the local and federalgovernment further adding to our financial crisis.Oral liquids contributed 55% of our sales, the sealing of this section hasaffected the sale of 13 other products. Moreover the company had to lay off30% of its employees.