MINUTES OF THE MEETING ON TESTING OF STREPTOKINASE HELD AT NIB ON 19.3.2009

A meeting was held under the chairpersonship of Dr. Jotna Sokhey, Additional DGHS & Director i/c, NIB, on 19.3.2009 to finalize the production protocol in consultation with the manufacturers and regulatory authorities and to discuss issues related to the preparation of National Reference Standard for Streptokinase.The meeting was attended by the representatives of Drug Controller General (I); M/s. Chandra Bhagat Pharma Pvt. Ltd., Mumbai; M/s. Gennova Biopharmaceutical Ltd., Pune, M/s. Samartha Life Sciences, Bangalore  and the concerned officers of NIB.The meeting notice had been issued to 18 manufacturers and importers of Streptokinase.The list of participants is annexed.

The Addl. DGHS & Director i/c, NIB, welcomed the participants to the meeting.She said that NIB was ready to start the testing of Streptokinase and the meeting had been convened to clarify matters related to the receipt of samples for testing, finalize the production protocol which is to be submitted with each batch sent for testing and also to work out the modalities for the preparation of national reference standard for Streptokinase.She said that the manufacturers and regulatory authorities were expected to send all the necessary documents along with the samples to enable NIB to test the products expeditiously and avoid delays in seeking clarifications etc.She said that the Institute would monitor turnaround time and make all efforts to send the test reports within 45 working days or earlier.The turnaround time would start after all documents and required number of vials had been received and therefore it would be in the interest of the party sending the samples to see that the laid down criteria were met.

Dr. A.K. Tahlan briefly reiterated the criteria for the acceptance of samples for testing at NIB.  He said that the information in this regard had already been circulated by DCG(I) to all the State Drug Controllers, regional drug control authorities and others.He said that care should be taken to lift samples randomly so that the entire batch was covered.He said that the batch should be interpreted as given in the Drugs and Cosmetics Act, 1940 and Rules there under (amended 2006).  If the filling was done on the same day, it was considered as one batch.However, if filling was done on different days, the same should be reflected in the production protocol and sterility tests recorded.The criteria laid down at NIB for the acceptance of samples and communicated to all concerned were :

1. Name and designation of the person signing the forwarding letter should be mentioned.

1. Box containing the samples should be sealed and intact.

Production Protocol and other related documents like valid manufacturing license; import license/export license, insert/leaflet, etc. should accompany the samples.

Required number of vials.

1. At recommended storage and transportation temperatures.

Within 3 months of date of manufacture for indigenous products and imported products to have at least 60% shelf life.

Dr.Tahlan mentioned that for imported products, import licence, CoA of the country of origin, name of the countries where this product was being used and production protocol with results of necessary tests conducted should be provided.

.NIB had indicated that 11 vials each of Streptokinase bulk and injection were needed for testing and an equal number are required to be kept as retained samples i.e. a total of 22 vials to be sent. 

Shri Somnath Basu, Technical Officer, CDSCO, said that the information provided in the production protocol was very important to assess the quality of the product.He mentioned that the detailed information should be provided in a dossier which should be submitted only once.If any changes were made, the production protocol should reflect these changes. Shri Basu said that at the time of landing at the port, the product must have at least 60% shelf life of its expiry.He also said that indigenous products should be sent for QC testing within three months from the date of manufacture.

Dr.J.P. Prasad, Scientist Grade-III and Head of the Enzyme and Hormones Laboratory, requested the participants for feed back on the draft production protocol which had been circulated along with the notice of the meeting.He said that attempt had been made to keep the protocol simple and include only the critical information needed for assessing the production steps and results of various tests during manufacturing and in the finished product.He said that the revised protocol would be circulated and posted on the website.

Shri Swarnendu Kaviraj, Assistant Manager (QC), M/s. Gennova Biopharmaceutical Ltd.,Pune said that they were manufacturing rec t-PA TNkase (Tenectaplase) in CHO cell lines.At present, no government authorized testing laboratory is carrying out batch release testing.The pharmacopoeia does not have a specific monograph for rec t-PA TN Kase.The matter may be taken up with IPC for necessary action.He also expressed a felt need for a National Reference Standard for t-PA.

Shri Pranav H. Bhagat and Shri Indranil Chakraborty representatives of M/s. Chandra Bhagat Pharma Pvt. Ltd., Mumbai said  that they were from the marketing division and were not aware of manufacturing details.The company imported bulk material from China.The bulk material is outsourced to M/s. Gufic Life Sciences, Pune, which further processes and markets as Streptokinase product.

Shri K. Narasimha Prasad, representative M/s. Samartha Life Sciences, Bangalore said that the firm also imported bulk material from China.The bulk material is outsourced to M/s. Gufic Life Sciences, Pune, which further processes and markets  as Streptokinase product.

The participants of the meeting supported the initiative taken by NIB for the preparation of National Reference Standard.As this would require a collaborative study with the manufacturers as per guidelines for preparation of National Reference Standards to validate and assign a unitage acceptable by applying harmonization methods,it was decided that another meeting may be convened to discuss these issues.No manufacturer was present at this meeting.Minor changes in the production protocol were suggested, which would be incorporated and the revised protocols circulated to manufacturers and importers by NIB.

            The meeting was concluded with a vote of thanks to the Chair.

LIST OF PARTICIPANTS