After its launch in Delhi last month, the Indian Pharmacopoeia (IP) 2007, having many new features to match with its counterparts in developed countries and encompassing over 1500 monographs, was formally released in Chennai on January 21. The new monographs would be made effective from April 2008.
Dr GN Singh of Indian Pharmacopoeia Commission released the massive document, prepared by the Indian Pharmacopoeia Commission. The release function was attended by Debashish Pandy, joint secretary, union ministry of health, Indian Pharmacopoeia Commission deputy director, south zone Shanti Gunasekharan, state drug controller Anbu Elango, other senior officials and industry representatives.
The new edition comes out in 3 volumes with 300 additional monographs has many new features. Besides, the 175 new monographs of chemicals and dosage forms, it has monographs on vaccines, immunosera, herbs, herbal products, blood and blood-related products, biotechnology and veterinary products.
The fifth edition of the standard-setting document has been prepared in accordance with the principles and designed plan decided by the Scientific Body of the Indian Pharmacopoeia Commission. In addition to the past practices of requesting for comments, the contents of revised appendices and monographs have been publicized on the website of the Indian Pharmacopoeia Commission, for collecting comments widely from various institutions and organizations.
The pharmacopoeia standards included in this publication adhere to the concept of harmonization with those used internationally, also keeping in view technological status for manufactures and analysis of different sectors of the industry, without compromising with the quality of the products.
Cross referencing has been avoided and uniformity of presentation of subject matter was kept. Categories of a drug, dosage & usual available strength of dosage forms have been omitted. Classical chemical tests for identification of an article have been almost eliminated & more specific IR & UV spectrophotometric tests have been introduced.
Use of Chromatographic methods has been greatly extended to cope with the need for more specificity in assays and test for pyrogens were virtually eliminated. The BET (bacterial endotoxin test) are going to be applicable to more items.
Wednesday, January 23, 2008
Tuesday, January 22, 2008
IDMA for strengthening CDSO, not in favour of CDA
Indian Drug Manufacturers' Association (IDMA) has suggested to the central government that the centre should strengthen the existing Central Drugs Control Organization (CDSCO) as recommended by Dr Mashelkar Committee and as declared in Pharmaceutical Policy 2002, instead of forming Central Drug Authority (CDA).
In a memorandum submitted recently to the joint director, Rajya Sabha Secretariat, the IDMA suggested that the centre should create strong, well equipped, independent and professionally managed CDSCO and to create separate division under CDSCO as per recommendations of Dr Mashelkar Committee. It has also suggested not to create a Central Drugs Authority by substituting a drugs Technical Advisory Board constituted under Section 5 of the Drugs and Cosmetic Act, 1940 and Ayurveda, Shidha and Unani Drugs Technical Advisory Board constituted under Section 33 C of the Act.
According to the IDMA, both these statutory bodies are broad based and are technical in nature. On the other hand, the proposed CDA will have only five members to be appointed by the central Government. The provision of section 5 of the proposed bill indicates that the central government is not bound to appoint technical experts on the Central Drugs Authority. It also said that the Drugs and Cosmetics Act, 1940 and its implementation is highly technical in nature and requires the advisory bodies comprising technically qualified experts.
It may be noted that the Drugs and Cosmetics (Amendment) Bill 2007 was presented in Rajya Sabha on August 21, 2007 and was later referred to the Parliamentary standing committee to examine and put forth its suggestions. The committee invited suggestions from pharma associations and other stake holders on formation of CDA and these associations and other stake holders sent their suggestions to the committee in writing.
In a memorandum submitted recently to the joint director, Rajya Sabha Secretariat, the IDMA suggested that the centre should create strong, well equipped, independent and professionally managed CDSCO and to create separate division under CDSCO as per recommendations of Dr Mashelkar Committee. It has also suggested not to create a Central Drugs Authority by substituting a drugs Technical Advisory Board constituted under Section 5 of the Drugs and Cosmetic Act, 1940 and Ayurveda, Shidha and Unani Drugs Technical Advisory Board constituted under Section 33 C of the Act.
According to the IDMA, both these statutory bodies are broad based and are technical in nature. On the other hand, the proposed CDA will have only five members to be appointed by the central Government. The provision of section 5 of the proposed bill indicates that the central government is not bound to appoint technical experts on the Central Drugs Authority. It also said that the Drugs and Cosmetics Act, 1940 and its implementation is highly technical in nature and requires the advisory bodies comprising technically qualified experts.
It may be noted that the Drugs and Cosmetics (Amendment) Bill 2007 was presented in Rajya Sabha on August 21, 2007 and was later referred to the Parliamentary standing committee to examine and put forth its suggestions. The committee invited suggestions from pharma associations and other stake holders on formation of CDA and these associations and other stake holders sent their suggestions to the committee in writing.
Monday, January 21, 2008
IPGA to announce date, theme of 60th IPC at Delhi
With the next Indian Pharmaceutical Congress (IPC) scheduled to be held in the national capital under the aegis of Indian Pharmacy Graduates Association (IPGA), the host organization will meet here on January 23, to set the ball rolling for the event by constituting the local organizing committee.
The IPG is planning to hold the 60th IPC in the second week of December 2008, preferably from Friday to Sunday. There was also suggestion for organizing the event in the first week of December. However, the dates for the mega event will soon be fixed in the meeting scheduled this month. Besides the venue, the theme of the conference also will be announced at the scheduled meeting.
It was announced in the last IPC held at Varanasi from December 20-23 that the prestigious pharma event will be held in Delhi under the banner of the IPGA, a member of the Indian Pharmaceutical Congress Association. DCGI Dr M Venketeshwarlu has been named as the president of the IPCA already.
``We are already in the process of finalizing the venues for the event. Hopefully, we will have a clear idea of everything in the first meeting itself. We are expecting 10,000 delegates this year, as all those from the industry and the academic circles are keen to come to Delhi,'' Nasa said.
The IPC at Varanasi, hosted by the Department of Pharmaceuticals of the Banaras Hindu University saw around 5000 delegates. Going by the expected number of delegates, the Delhi event is going to create a record of sorts. Hence, the IPGA is looking for elaborate arrangements to outshine the past events.
Indian Pharmaceutical Congress Association (IPCA) is the apex body representing Indian pharmacists working in various capacities, viz. community pharmacists, hospitals pharmacists, in industry (in production, R&D, quality control, quality assurance and marketing), regulatory officials, academicians and other disciplines and areas of work.
Having over 20,000 pharmacists as its members, it has five constituents - the Indian Pharmaceutical Association, the Indian Pharmacy Graduates Association, the Indian Hospital Pharmacists' Association, the Association of Pharmaceutical Teachers of India and the All India Drugs Control Officer's Confederation. The first IPC was held in Kolkota in 1948. The Varanasi IPC has the theme of `Pharma Vision 2020 - product, patient, practice.'
The IPG is planning to hold the 60th IPC in the second week of December 2008, preferably from Friday to Sunday. There was also suggestion for organizing the event in the first week of December. However, the dates for the mega event will soon be fixed in the meeting scheduled this month. Besides the venue, the theme of the conference also will be announced at the scheduled meeting.
It was announced in the last IPC held at Varanasi from December 20-23 that the prestigious pharma event will be held in Delhi under the banner of the IPGA, a member of the Indian Pharmaceutical Congress Association. DCGI Dr M Venketeshwarlu has been named as the president of the IPCA already.
``We are already in the process of finalizing the venues for the event. Hopefully, we will have a clear idea of everything in the first meeting itself. We are expecting 10,000 delegates this year, as all those from the industry and the academic circles are keen to come to Delhi,'' Nasa said.
The IPC at Varanasi, hosted by the Department of Pharmaceuticals of the Banaras Hindu University saw around 5000 delegates. Going by the expected number of delegates, the Delhi event is going to create a record of sorts. Hence, the IPGA is looking for elaborate arrangements to outshine the past events.
Indian Pharmaceutical Congress Association (IPCA) is the apex body representing Indian pharmacists working in various capacities, viz. community pharmacists, hospitals pharmacists, in industry (in production, R&D, quality control, quality assurance and marketing), regulatory officials, academicians and other disciplines and areas of work.
Having over 20,000 pharmacists as its members, it has five constituents - the Indian Pharmaceutical Association, the Indian Pharmacy Graduates Association, the Indian Hospital Pharmacists' Association, the Association of Pharmaceutical Teachers of India and the All India Drugs Control Officer's Confederation. The first IPC was held in Kolkota in 1948. The Varanasi IPC has the theme of `Pharma Vision 2020 - product, patient, practice.'
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