Sri Lanka blacklists Indian drug suppliers

Sri Lanka's Ministry of Health has blacklisted at least a dozen of Indian drug suppliers for violating tendering procedures and supplying low quality medicines, officials said.

Health Minister Maithripala Sirisena has directed his officials to look elsewhere for supplies to meet urgent requirements, officials added.

"I have been told by my officials that Indian companies have violated tender procedures or have supplied low quality drugs," Sirisena was quoted as saying in local press. The Indian companies' shortcomings have led to shortages in some urgently needed medicines, officials charge.

Around 100 Indian drugs suppliers are in the Colombo Health ministry's suppliers roll, but the companies in the spotlight have been blacklisted for supplying sub-standard medicine while paying no heed to deadlines for supply and violating procedures.

WHO and partners call for action on 'Partnerships for Health'

The three-day conference, Partners for Health in South-East Asia, organised by the World Health Organization concluded in New Delhi. The Delhi Call for Action on Partnerships for Health was issued by representatives of national governments, parliamentarians, academia, civil society, patients rights groups, NGOs, the private sector, professional organisations, bilateral and multilateral donors, global health partnerships, development partners, media and UN organisations attending the conference.

The conference discussed health partnerships that are already working and explored innovative ways to improve their effectiveness. The interrelation of health issues and underlying problems such as lack of sanitation, gender and human rights, and fragmented systems was stressed. It was noted that not just more money, but also more openness and tolerance are sometimes what is need to make health programmes work. Participants frankly discussed such problems and ways to solve them.

The eleven countries of WHO's South-East Asia region hold more than a quarter of the world's population and bear a disproportionate share of the global disease burden. These diseases include a heavy burden of maternal and child mortality and morbidity, infectious diseases such as malaria, tuberculosis, HIV and neglected tropical diseases such as leprosy and dengue, as well as emerging threats like SARS and pandemic influenza.

In addition, the conference expressed concern that noncommunicable diseases (NCDs) including cardiovascular diseases, cancer, diabetes, chronic respiratory diseases, and conditions such mental illness, injuries and disabilities, are

placing a further burden on health systems and society. NCDs account for more than half of annual deaths in the Region, and affect the poor as much as those better off.

Both natural and human factors contribute to the Region's vulnerability. The region's susceptibility to natural disasters, rapid demographic and epidemiological transition, limited and inconsistent political support and uneven implementation of health-promoting laws increase this vulnerability.

The conference acknowledged that strong health systems based on the primary health care (PHC) approach are the cornerstone of achieving better health outcomes. But health systems in the Region too often remain ineffective, too medically oriented, underfunded, and fragmented, and are further challenged by difficulties in training and retaining health workforce.

The health challenges with social, political and economic determinants can only be addressed by a spectrum of partners acting decisively and in concert. The community itself must be empowered so that it can be a partner in improving health.

The Partners resolved to accelerate efforts towards achieving key goals and targets outlined in the Millennium Development Goals (MDG) in consonance with national development priorities and through revitalisation of primary health care.

Maharashtra FDA detects 20 not-of-standard drugs in April

The Maharashtra Food and Drugs Administration (FDA) has detected 20 not-of-standard drugs during the month of April in the random sample testing. In April manufacturers from the tax-free state of Himachal Pradesh with 10 and Maharashtra with 5 not-of-standard drugs accounts for the major share.

Well-known drug manufacturers like ASA Biotech for Miscef-100, Athens Labs for RT-Zyme syrup, Ion Healthcare for Rabeprazole sodium tablets, Emcure Pharmaceuticals for Orofer XT suspension, Ciron Drugs & Pharmaceuticals for Co-Trimoxazole paediatric mixture IP/Co-Trimoxazol and Rhydburg Pharmaceuticals for Becoplex Forte also figure in the list.

Other highlights of Maha FDA's not-of-standard drugs list include - samples for not complying with IP requirements Atul Pharmaceuticals (Bethasone tablets), Affine Formulation (Prima 7.5 tablets/primaquine phosphate tablets), Ion Healthcare (Rabeprazole sodium tablets), Magbro Healthcare (Rabeprazole sodium tablets), Mission Laboratories (Healsera tablets), Prashi Pharma (Davithro 500/ Erythromycin stearate tablets).

Out of 20 such drug samples found in April, 10 were from Himachal Pradesh, five from Maharashtra, two from Gujarat and one each from Jammu and Kashmir, Uttaranchal and West Bengal.

During April other companies in the FDA list include: Atul Pharmaceuticals and S R Pharmaceuticals from Gujarat; Affine Formulation, ASA Biotech, Athens Labs, Elfin Drugs, Health Biotech, Ion Healthcare, Magbro Healthcare, Mission Laboratories, Orison Pharma International, Skyline Pharma from Himachal Pradesh, Emcure Pharmaceuticals from Jammu and Kashmir; Prashi Pharma, Snow Chem Industries, Zim Laboratories, Ciron Drugs and Pharmaceuticals from Maharashtra, Rhydburg Pharmaceuticals from Uttaranchal and C I Laboratories from West Bengal.

The state FDA routinely picks up random samples of drugs from chemists and druggists and sends for testing. The Department will soon issue show cause notices to these companies

ICMR improving quality of project audits for timely, tangible results

The Indian Council of Medical Research (ICMR) is further equipping the existing system to improve the quality in auditing of on-going intramural projects with a view to ensuring timely and tangible results of the projects taken up under its different institutes.

As part of a three-tier system in place for auditing, a scientific advisory committee (SAC), comprising of subject related experts, assists each ICMR Institute and the centre. The SAC oversees the research activities including review of on-going projects and clearing new project.

The ICMR now is adding new parameters to improve the quality of auditing like assessment of promising leads and ensuring of basic translational research at the institute levels. The ICMR is also seeking further technical and financial resources for the SAC.

There is also a Scientific Advisory Board (SAB) comprising 21 members representing different institutions and disciplines, as specified in the Rules and Regulations of the ICMR, to review the reports. It also recommends advisory groups and offers advices to the ICMR.

The recent meeting of the SAC reviewed the progress made in developing a vaccine against AIDS among other projects recently. “A phase I HIV vaccine trial using the prime boost approach was initiated in NARI, Pune and TRC, Chennai. The enrolment for the trial has been completed and the volunteers are now being followed,” sources said.

New proposal on “ICMR- Indian National Diabetes Study-Phase I,” has been initiated at three states and one Union Territory with the aim to understand prevalence of diabetes and pre-diabetes along its association with the genetic aspects, the meeting was told.

Guidelines on Management of buccal mucosa and cervical cancer have been finalised. As part of a multi-centric Management of Acute Coronary Event Registry project, a web-based questionnaire had been designed and is currently being validated by entering data from patients registered by MACE registries at different centres.

Central Drugs Standard Control Organization (CDSCO) recruits

The Central Drugs Standard Control Organization (HQ), FDA Bhawan, Kotla road, Near
Mata Sundari College, New Delhi - 02 requires Professional Consultant, Technical Data Associates, Data Entry Operators and Office Assistants purely on contractual basis upto 30.09.2011. These supporting staff will assist Senior Officers in matters related to Administrative/ Technical works carried out in the office of CDSCO. Qualification, experience, job description, emoluments etc. for various posts are as under:-

1)Professional Consultants

a) Professional Consultant Medical Devices @ Rs. 50,000/- p.m

Age: 35 - 65 years
Qualification:
(i) Master degree in Chemistry / Pharmacy/Biochemistry or Degree in Bio-Medical
Engineering with 10* years experience in Manufacture/Testing/ Research/Regulatory affairs
of Medical Devices.
Job Description:-
1. To collate, compile and analyse the scientific national, international data/regulation of
medical devices.
2. To make relevant SOP’s, guidelines and notification for amendments in Schedule M-III
and M-IV to Drugs & Cosmetics Rules.
3. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(b). Professional Consultant Diagnostic Kit @ Rs. 50,000/- p.m
Age: 35 - 65 years
Qualification:
(i) Master degree in Pharmacy/ Medical Lab Technology/ Biochemistry/ Microbiology or
degree in Bio-Medical Engineering with 10* years experience in Manufactures/ Testing/
Research /Regulatory affairs of Diagnostic kits.
Job Description:-
1. To collate, compile and analyse the scientific national, international data/regulation of
Diagnostic kits.
2. To make relevant SOP’s, guidelines and notification for amendments in Schedule M-III
and M-IV to Drugs & Cosmetics Rules.
3. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(c) Professional Consultant Pharmacovigilance (Tech.) @ Rs. 50,000/- p.m
Age: 35 - 65 years
Qualification:
Master degree in Pharmacy with pharmacology or clinical pharmacy with 10* years
experience in collation/ analysis of ADR reports.
Job description:-
To prepare the blueprint for collection, Collation, analysis of ADR reports, received
from various centres all over the country and implementation of the Pharmacovigilance
programme. Preparation of guidelines / documentation etc. for the programme. Co-ordination
of spurious drugs survey at National Level. Any other duties assigned by Drugs Controller
General of India (DCGI) from time to time

(d) Professional Consultant Biopharmaceuticals @ Rs. 50,000/- p.m
Age: 35 - 65 years
Qualification:
Master Degree in Pharmacy with Pharmacology or clinical Pharmacy or M.Sc. in Clinical
Chemistry with 10* years experience in manufacturing/testing/Regulatory Affairs of
Biopharmaceuticals
Job description:-
- To prepare guideline documents for conducting Clinical Trials, manufacturing and
testing of Biopharmaceuticals
-To facilitate the preparation of guideline document for approval of New
Drugs(Biopharmaceuticals) and for CRO centers.
-Any other duties assigned by DCG(I) from time to time.

(e.) Professional Consultant Clinical Trial @ Rs. 50,000/- p.m
Age: 35 - 65 years
Qualification:-
Master degree in Pharmacy with pharmacology or clinical pharmacy with 10* years
experience in co-ordination/ documentation/ management of Clinical Trial.
Job description:-
1. To facilitate the preparation of SOP’s, guidelines, roadmap for
registration of CROs, Ethics Committees; inspection of Clinical Trial sites, sponsors
/CROs ; GCP training etc
2. To facilitate the preparation of guidance document for approval of various categories
of new drugs , clinical trials including micro dosing (phase zero) and phase –I clinical
trials.
3. Any other duties assigned by Drugs Controller General of India (DCGI) from time to
time

(f).Professional Consultant Cosmetics @ Rs. 50,000/- p.m
Age: 35 - 65 years
Qualification:-
Master degree in Pharmacy with 10* years experience in manufacturing/ testing of cosmetics.
Job description:-
1. To prepare the SOP’s, Guidelines on regulation of import of cosmetics.
2. To maintain Documentation & Data-base
3. Any other duties assigned by Drugs Controller General of India (DCGI) from time to
time

(g). Professional Consultant IT Services @ Rs. 50,000/- p.m
Age: 35 - 65 years
Qualification:-
1. B-Tech /B.E (computer science) or MCA
2. 5 years experience in management/ development of software in a reputed organization.
Job description:-
1. To facilitate E- governance project.
2. To train the staff to implement E- Governance and File Tracking System.
3. Development of electronic Archiving and retrieval system.
4. To maintain Documentation & National Data Bank.
5. Upgradation of website and its up keep.
6. Installation of Video conferencing facilities with wi-fi system.
7. Preparation of user manual etc.
8. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(h). Professional Consultant Quality Management System @ Rs. 50,000/- p.m
Age: 35 - 65 years
Qualification:
Master degree in Pharmacy with 10* years experience in quality management in
Pharmaceutical field.
Job description:-
1. To facilitate implementation of quality management system and its monitoring.
2. Training of staff
3. Harmonization with national/ international QMS progress.
4. To prepare and maintain documentation
5. Preparation of guidelines/ operating documents for the organization.
6. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time
* 10 years experience may be relaxed for highly skilled and qualified candidates.

2. Technical Data Associate (22 Posts) @ Rs. 19,000/- p.m
Qualification:-
The candidates should be B. Pharmacy or M.Sc. in Biochemistry, Pharmaceutical
Chemistry/Organic Chemistry/Microbiology/ Biotechnology. The candidates should
also have sound knowledge of computer operation. Preference will be given
candidates having experience in manufacturing/ testing of drugs/drugs regulatory
affairs.
Job description:-
To assist officers of CDSCO in scrutiny/examination of technical documents
pertaining to import registration, Import license, new drug approval, Central Licence
Approving Authority (CLAA) items and various NOCs. Documentation, Creation and
maintenance of National Data Bank. Any other duties assigned by Drugs Controller
General of India (DCGI) from time to time.
government servant having experience in the field of administration and finance.

3. Data Entry Operator ( 18 Posts) @ Rs.10,000/-p.m.
Qualification:
The Candidates should be Graduate with 1 year Diploma in computers from recognized
Institute. The candidates should have typing speed of 40 w.p.m. Preference will be given to
candidates also having short hand knowledge.
Job description:-
Typing of various letters, approvals, licenses, noting etc. Alongwith documentation, Creation
& maintenance of National Data Bank. Any other duties assigned by Drugs Controller
General of India (DCGI) from time to time.

Fixed Dose Combination (FDC) issue - will there be an end to it ?

A lasting solution to the vexed Fixed Dose Combination (FDC) issue, which has been evading a solution for almost four years, does not appear to be on the cards as the expert panel, headed by DCGI, is adamant that the industry should come out with clinical trial details on each of the FDC products, even those products which were in the market for decades together.Industry sources said that the expert panel, which consisted of doctors from renowned hospitals, was not ready to even consider the drugs which were in the market for several years. Though the industry also took the help of several renowned doctors, that too specialists in each area, the panel simply refused to consider the pleas of these doctors and insisted on clinical trials for each of the FDC products, sources said.

After a long gap of more than one year, the expert panel on FDC held its meeting on April 19 and 20 this year to take a call on most of the remaining FDC drugs. In fact, the industry was optimistic on finding a lasting solution to the vexed issue during the two-day meeting, especially in the wake of DCGI Dr Surinder Singh's public announcement on January 7 this year in Mumbai that the long pending FDC issue would be resolved within one month. On that day, the DCGI was addressing the captains of Indian pharma industry on the occasion of the 49th annual day celebrations of the Indian Drug Manufacturers Association (IDMA) in Mumbai.But the insistence of the DCGI-headed expert panel on clinical trial for all the products has belied such a hope.Taking strong exception to the adamant attitude of the panel, industry sources said that if the DCGI wanted clinical trials for every product, the entire exercise of holding periodic meetings between the industry and the expert panel is a waste of time for one and all. “The industry has roped in several renowned doctors to present their case in the meetings. But, their views were not heeded by the panel,” the industry regretted. In fact, the industry is annoyed with the DCGI over his indifferent attitude in handling the entire FDC issue. There is resentment among the industry over the inordinate delay on the part of the DCGI in sending the list of FDCs, which have been accepted as 'good and rational' by the expert panel, to the State Licensing Authorities (SLAs) as the SLAs are directing the companies to approach DCGI office in Delhi for getting the license renewal of drugs which have been in the market for as long as 10 to 15 years. The expert panel on FDC had so far cleared more than 200 of the total 294 controversial combination drugs as 'good'. But, the DCGI is yet to officially communicate the same to the SLAs in writing, leaving the industry to approach the DCGI office for licenses.

26th IPGA conference pushes for change in pharmacy education

The 26th Annual conference of the Indian Pharmacy Graduate's Association (IPGA) was held on April 2, 2011 in New Delhi, with the theme of 'Pharma opportunities and challenges in the new decade'. Even though the event clashed with the finals ICC World Cup, with India as one of the teams, the event was very well attended, a sign that the topic was as great a pull as the game. Dr S S Ghonkrokta, Director-Enforcement, Food Safety and Standards Authority of India (FSSAI) was the guest of honour, while Dr S M Jharwal, Chairman, National Pharmaceutical Pricing Authority (NPPA) was the chief guest for the occasion.

In his keynote address, Professor S K Kulkarni, Bombay College of Pharmacy, touched on the aspect of 'building an innovation eco-system in pharmaceutical sciences', saying that the quality of education and research done in our country needs to be looked at with concern because the goals still needed to be met. There is a shortage of specialised talent in system biology, clinical research, healthcare delivery and so on, which are disappointingly not in the regular pharmacy curriculum and need to be introduced in pharmacy education in order to rightly equip students with the knowledge base to thrive professionally. "The current lack of research infrastructure and funding (private and public), lack of inter and cross disciplinary teaching and learning, unmindful expansion of professional education are all distressing factors that exist because the right priorities are not kept in mind," said Kulkarni. "To overcome this and to establish an innovation eco-system there is a great need to firstly shun the old and unproductive mindset in the industry and overhaul educational and research approaches with vigour and imagination in order to contribute to the global knowledge bank. Secondly, we need to adopt flexible and interdisciplinary learning modes, while rightly identifying ambitious young individuals and institutions; fund, network and establish credible environment of entrepreneurs and alumni," he added.

Among the speakers present at the event, Mukta Arora, India Head-Global External R&D and Global Sourcing India Market, Eli Lilly and Company traced the evolution of the Indian Pharma industry with respect to the various niches and identified opportunities for students in the fields of manufacturing of api, CT material, drug product; research, clinical research, formulation research, in sales and marketing jobs at Indian and MNCs, community pharmacist, market research, hospital pharmacy management, drug development--adme/tox/safety, medicinal chemistry, synthetic chemistry, natural products research, large molecules-biologics, regulatory--clinical, and pharmacovigilence.

While Dr Veena Kohli, Vice President, Diagnova, RFCL, talked about the opportunities for students in the field of medical diagnostics, Dr B R Jagashetty, Drugs Controller, Karnataka, gave an insight into the vast field of regulatory affairs pertaining to pharmaceuticals. Dr Jaspreet Kaur, Head Quality Assurance and Training, Fortis Clinical Research, Faridabad, enlightened pharmacy students about career in clinical research, and Dr Varun Katyal, Assistant Professor, Empower School of Health, spoke about the more sought after fields that pharmacy students would be interested in and the right educational pathway to follow to pursue them.

The conference saw delegates from all over the country, from regulatory departments, the pharma industry, R&D, hospital, community and clinical pharmacy, academia, marketing and pharmacy students. Later in the evening, Priolkar was felicitated as the President Elect for the 63rd Indian Pharmaceutical Congress, 2011.

Maharastra FDA to launch software for pharma units to enable access to all drug information soon

As part of its plan to introduce e-governance, the Maharashtra Food and Drug Administration (FDA) will soon introduce a new software which will be beneficial for thousands of drug manufacturers spread across the state as they can access all drug related information and status of pending works through online thereby saving a lot of time and energy.

The software will have several user-friendly features and the manufacturers do not have to visit the FDA office frequently as they can access everything online regarding drug manufacturing processes. The other features include process of additional products, certification of the products required for manufacturing purpose and any pending approvals of manufacturers, etc.

O S Sadhwani, joint commissioner, Maha FDA said “Gujarat Food & Drugs Control Administration (FDCA) is already using this software and if they are successful then we will use it across Maharashtra. We are at the primary stage of starting a software which will prove to be beneficial for the manufacturers. There are further talks regarding the meeting with National Informatics Centre (NIC) for the use of the software and for further developments we will follow the path of Gujarat FDCA as it has already implemented it in Gujarat.”

Sadhwani added that Maharashtra FDA had already approached NIC to develop software for online facility for granting licenses to the pharmacists across Maharashtra which was a successful initiative that helped the retailers to save time while applying for licenses and renewals. Likewise by introducing this software FDA is hopeful that it will help manufacturers to complete their pending work.

In the first stage, the Maharashtra FDA will be implementing this software in Konkan division which comprises Thane, Ratnagiri, Raigad and Sindhudurg. After launching this software in Konkan , then it will be used by manufacturers across Maharashtra for a specific period of time. This will help the manufacturer to analyse and complete their pending work or understand what are the need for manufacturing purpose.

As of now the FDA will focus on building the data, but in future they are hoping to continue and will be concentrating on developing the software for manufacturers and most importantly to get the right information about the pending products and approvals.