Gujarat FDCA plans to strengthen drug withdrawal system through e-governance

The Gujarat Food and Drug Control Administration (FDCA) is mulling over an idea to utilise its e-governance system to strengthen the drug withdrawal system in the state by alerting the retail pharmacists and the district level regulatory officials on any batch of medicines found not of standard quality in the drug testing lab.

The FDCA, which is in the final stage of completing the e-governance project to issue sales and product licenses for drugs through online and monitoring, has moved a plea to the state health ministry to allot fund to add a software to the existing system for the purpose.

Through the software, all the licensed retail pharmacists would automatically alerted through short message services (SMSs) right at the time when a not-of-quality standard or spurious drug test result is fed into the computer in the state drug testing lab, said H G Koshia, commissioner, Gujarat FDCA.

Training Programme on Proposal Development & Report Writing for Development Projects

Excella Orbit, the training division of Sambodhi Research & Communications Pvt. Ltd., is organising a Training Programme on Proposal Development & Report Writing for Development Projects to be held at New Delhi from 05 – 06 March, 2010.

The course aims to facilitate a shared understanding of importance of structure, organization and articulation in proposals and report writing and enhancing knowledge for developing clear, concise and high-impact proposals. This course also provides trainees with an augments skills for organization and presentation of contents of event report and research/study reports perspective on professional. This also enables students in building greater confidence in producing effective written communication.

The programme brief is discussed below.
The course shall provide:
• 16 hours of tutorial
• Reading Material and aids
• Rigorous hands on practice
• Complementary advisory and troubleshooting support services through electronic media.

Interested people can send an email requesting for the flyer and registration form. Discounts available for group registration. Last date for registration is 25th February, 2010.

Contact:
Excella Orbit
Sambodhi Research and Communications Pvt. Ltd.
O2, 2nd Floor, Lajpat Nagar
New Delhi -110024
Phone :+91-11-40560734/ 65492502
www.sambodhi.co.in; www.excellaorbit.com

Biogen to bring its global drug portfolio to India

US-based Biogen Idec plans to roll out its entire range of medicines in the fast-growing, Rs 40,000-crore Indian retail drug market over the next few years through its wholly-owned Indian arm.

The company has also not renewed its product distribution agreement with Piramal Healthcare which expired last December, a top company official said. “Our five-year marketing tie-up with Piramal Healthcare for Avonex expired last year-end. The drug is now being sold by our own sales team,” said Biogen Idec Biotech India managing director Alpna Seth.

Biogen Idec, one of the largest biotech drugmakers globally, had set up its wholly-owned Indian subsidiary in 2007, but the firm was not engaged in commercial activity.

MS Pharmacy students planning to seek legal intervention

With the PCI firm on not approving the MS program for registration with Pharmacy council for the practice of Pharmacy, the NIPER administration has seeked the support of AICTE since PCI does not regulate the post graduate education.

With things uncertain, a large number of students who pursued/pursuing this course are in crossroads thinking about the profession to teach. Now the students are planning to take this issue to the Supreme court and ask for a legal intervention.
We got to wait and

Proffessional training for newly recruited Drug Inspectors of Tamilnadu.

For the first time ever by a state Government, the Drugs Control Department in Tamil Nadu, has planned for a week long training programme on Drug Regulation and Pharmaceutical Management to the newly recruited drug inspectors.

Areas of focus during this training program will be on the awareness of Drugs & Cosmetics Act, Narcotic Drugs and Psychotropic Substance Act, Evidence Act, CrPC, RTI Act, DPCO, training on Blood Banking and Drugs & Magic Remedies (Objectionable Advertisement) Act.

Trainers for this program will include the staffs of the Drugs Control Department, academic faculties, retired Drug Controllers and specialized officers from the police department.
This recruitment of officers to the state drug control body happens after a long gap of ten years and this training program sounds to be great start for the new recruits.

Wishing the new Drug Inspectors a very good luck!

Pondicherry Pharmacy Council resumes issue of registration of certificates after 5 years

With the appointment of a new Registrar, the Pharmacy Council of Pondicherry has resumed the renewal and fresh issuance of registration certificates to graduates of pharmacy from February 10. On Wednesday the Council issued 30 new registration certificates to 30 B Pharm Graduates.

The registration of certificates had been held up indefinitely for want of a registrar for the last five years. The government has appointed a new registrar one month ago.

On February 10, the inauguration of registration was done by the Union Territory’s Health & Family Welfare director, Dr.Dilip Kumar Baliga, said the new registrar, L. Sathyanarayana. Registration for another 66 certificates that are pending, some of which include those of post graduates, will be cleared in another one week.

According to the Registrar, since every pharmacy graduate or post graduate has to renew his or her certificate every year in Pondicherry, it is difficult for them to pursue a job or research work. So he is planning to put his idea into the next council meeting to get the registration validity period extended up to a minimum of five years. He said in certain states, one registration is valid for the life-time except change of photo in five years.

Another initiative from the registrar’s side is nothing but an effort to get the favour of the Central Council. Pondicherry pharmacy council has to give a sum about Rs 10,000, which was also pending for half a decade, to the Pharmacy Council of India. Every state pharmacy council has to give one-fourth of its registration fees to the central council for its functioning, as per the PCI Act. For this, the new registrar has engaged some internal auditors to audit the account balance and, he said, the dues will be cleared in one month’s time.

In the wake of revival of the council after constitution with elected members on September 30 last year, the office of the Council has been shifted to the new building situated in the premises of Government Pharmacy Campus in the city from Muringapakkam Government hospital building where the it was functioning from its inception.

The new registrar, L Sathyanarayana was working as a government pharmacist in the medicinal supply division in Gorimdu. In Pondicherry, as per the Territorial Act, a government servant with B Pharm Degree would be eligible to become the Registrar of the Council.

According to traders of pharmacy in Pondicherry, shortage of registered pharmacists has often put them into quandary as they could not adhere to the norms of D&C Act in appointing pharmacists in their shops.

Centre approves expansion of reservation for OBCs in PGIMER, Chandigarh

The Central government has approved a proposal from the Union Health Ministry for expansion in Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh for implementing 27 per cent OBC reservation.

With the introduction of 27 per cent reservation for OBCs in all institutes under the Central Government, the total percentage of reservation will go up from the present level of 22.5 per cent to 49.5 per cent. It will provide reservation to OBCs in admission to this Institute under Central Government.

On implementing the reservation for OBC in the Institute, an additional 214 Post Graduate seats would be created increasing the total number of seats from 396 to 610. Further, an additional 192 seats in Nursing Courses would be created increasing the total number of seats from 360 to 552. Also, an additional 87 seats in Paramedical Courses would be created increasing the total number of seats from 160 to 247.

Indian pharma in midst of corporate transformation

Leading Indian drug companies such as Dr Reddy’s Laboratories, Sun Pharma, Glenmark and Lupin are now in a transformation mode, from traditional family-run businesses to corporations run by high-profile professionals.

If most of the top 10 Indian drug companies were less than Rs 500-crore turnover ones a decade earlier and were focused only on domestic business, now they are companies with annual businesses ranging from Rs 2,000-Rs 6,000 crore and with operations spanning 60-100 countries and employing 3,000-5,000 people.

Sun Pharma, now an over Rs 4,000-crore company and India’s largest drug manufacturer in terms of market capitalisation, will soon have a new chief executive officer, S Kalyanasundaram, former managing director of GlaxoSmithKline Pharmaceuticals (GSK India) and GSK’s Asia Pacific director. The 26-year-old company was so far headed by Dilip Shanghvi, chairman and managing director, and his brother-in-law, Sudhir Valia, whole-time director.

Last week, Dr Reddy’s Laboratories, the largest Indian drug maker, brought in Sanjeev Verma, a former Moser Baer, Max New York Life and Dell executive as the new head for corporate communications and branding.

The Rs 7,000-crore company, which re-organised its entire drug research and generics business focus last year, had then appointed former Eicher and PepsiCo executive, Umang Vohra, as chief financial officer (CFO) and elevated Saumen Chakraborty, former CFO and HR head as president–corporate and global generics operations.

More info here

Pharma cos hope R&D sops in budget will boost investment

Indian drugmakers could see excise duty on drugs restored to 8% from the present 4%, but they are hopeful research & development could attract some tax sops in the Union budget on February 26.

Industry players and analysts expect tax sops for R&D to push investments in the sector.
Sudhir Singhi, chief financial officer, Aurobindo Pharma, said the government might restore the excise duty on drugs to 8% from the present 4% offered as part of the first economy stimulus package in December 2008, to ease the effects of a debilitating global financial crisis.

Drugmakers are expecting R&D to be a major bet in terms of easing regulation to boost the sector in the country.
"The government should increase the weighted tax deduction on R&D activities up to 200% from the present 150%," said Dishman Pharma's Managing Director JR Vyas.
"This will prove to be a major boost for domestic R&D activities," said Sundeep Bambolkar, director-finance and operations, Indico Remedies Ltd.
Bambolkar also wanted complete income tax exemption on exports to be extended to pharma companies

"The industry has been pressing for additional sops on R&D and exports fronts. We can expect some announcement in this regard," said another sector analyst.

Sibutramine Now Contraindicated in Patients With a History of Cardiovascular Disease

Sibutramine, marketed as Meridia in the United States by Abbott, is now contraindicated in patients with a history of cardiovascular disease. According to the U.S.FDA, the drug label already warns against the use of sibutramine in patients with cardiovascular disease. "However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label," stating that sibutramine should not be used in patients with a history of cardiovascular disease, including patients with a

* History of coronary artery disease (eg, myocardial infarction, angina

* History of stroke or transient ischemic

* History of heart

* History of congestive heart

* History of peripheral arterial

* Uncontrolled hypertension (eg, >145/90 mm Hg)

The safety review was based on data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT), which enrolled more than 10,000 overweight or obese patients with diabetes or a history of coronary artery disease, peripheral vascular disease, or stroke, along with other cardiovascular risk factors.

An analysis of the trial's primary end point — a composite of myocardial infarction, stroke, resuscitated cardiac arrest, or death — found the rate to be 11.4% for patients receiving sibutramine and 10% for those receiving placebo. The current review found that the risk for cardiovascular events with sibutramine was significantly increased only in patients with a history of cardiovascular disease (P = .023).

Healthcare professionals should regularly monitor blood pressure and heart rate in patients taking sibutramine, the FDA notes."If sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued, " according to the FDA. "Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first 3 to 6 months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk."

PCI does not recognize: MS programme in Industrial Pharmaceutics and Pharmaceutical Analysis & Quality Control

Pharmacy Council of India (PCI) chairman Dr B Suresh has justified the Council’s decision not to recognize the MS programme in Industrial Pharmaceutics and Pharmaceutical Analysis & Quality Control being conducted by premier institutions including NIPERs in the country on the ground that there is no mandatory infrastructure in these institutions to conduct the MS programmes.

“We don’t know the content and the structure of the course being conducted by these public as well as private institutes. There is no proper infrastructure available in these institutions for conducting a prestigious programme like MS. In Hyderabad NIPER, they have admitted 60-70 students for the MS programme with just two teachers. The situation in Guwahati NIPER is also not different as they have also admitted 60-70 students for MS programme with some visiting faculty alone. Only name of NIPER cannot ensure quality of education”, Dr Suresh said.

The PCI chairman regretted that it is the exploitation of the gullible students who don't know the fact that the MS programme is not recognised by the PCI for pursuing pharmacy teaching profession in the country. But, the course is being run by the NIPERs where the teachers know everything. They are doing this just for money. If government institutions can resort to this kind of practice, what to say about private institutions, he asked.

He said that there is simply no reason why the students who aspire to become pharmacy teachers should join MS programme conducted by these institutes when M.Pharm seats are easily available in other prestigious pharmacy colleges in the country. Many students even do not know that the MS programmes conducted by these institutes are not recognised by the PCI. “So, it was our duty in the interest of the student community to bring to their notice that the MS degree is not recognized by the PCI for teaching purposes. That is why we have announced it in our website”, he said.

Though these students cannot become pharmacy teachers, there are several other avenues for them to pursue in their career in the industry, Dr Suresh said. There are several degrees in medicine, like MRCP, etc which are not recognized by MCI for teaching, but even then doctors go abroad and take the degrees and start practising here, he added.

Biocon explores investment in Malaysia

Biocon explores investment in Malaysia Bangalore, 24 January Biocon Limited, the country's second largest biotechnology firm has signed a Memorandum of Understadning (MoU) with Malaysia's Biotechnology Corporation (BiotechCorp) to explore collaboration and potential investment in Malaysia's biotechnology industy.

Biocon is in talks with Biotechcorp to manufacture biopharmaceutical products and formulation, within Malaysia's Nusajaya, Iskandar Malaysia, in the biotech park called the Bio-XCell Ecosystem.Biocon is also developing biotechnology infrastructure in the Bio-XCell Ecosystem Project. BiotechCorp is the lead development agency for the biotech industry in Malaysia and acts as a central contact point providing support, facilitation and advisory services for biotech and life sciences companies in Malaysia.

Kiran Mazumdar-Shaw, chairman and managing director, Biocon said, "The company is keen to explore Malaysia as a destination for our expansion. Malaysia and the Bio-XCell Ecosystem in Iskandar Malaysia are attractive propositions."

Safety Risk Associated with HIV Drug

FDA recently announced the potential risk associated with Videx/Videx EC (didanosine). Non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC, an antiretroviral drug first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.

During an 18-year period, 42 cases of non-cirrhotic portal hypertension were reported to the FDA’s Adverse Event Reporting System for patients taking Videx/Videx EC. Four patients died from bleeding or liver failure after developing the condition.

Non-cirrhotic portal hypertension occurs when blood flow in the portal vein – a major vein in the liver – slows down and leads to severely enlarged veins in the esophagus. These enlarged veins, called esophageal varices, are thin and can break open, resulting in serious, and potentially fatal, bleeding.

The Videx and Videx EC product labels have been revised to help ensure that health care professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.

The FDA evaluation concluded that the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks. Videx/Videx EC does not cure HIV infection, may not prevent development of HIV-related illnesses, and may not prevent the spread of HIV to other people.

Videx/Videx EC is marketed by Princeton, N.J.-based Bristol-Myers Squibb.

Pharmacovigilance workshop in Chennai

DIA has organized a workshop "Pharmacovigilance and Risk Management" in Chennai on February 20-21, 2010.

Featured Topics
• Risk Management

• National pharmocovigilance programme: Progress, Status and Challenges

• KPO-Pharmacovigilance Model
• Human Resource Development in Pharmacovigilance
• Management of Pharmacovigilance the MNC Way
• Pragmatic Approaches to Pharmacovigilance in Light of CIOMS Pharmacovigilance Working Group Recommendations
• Regulatory Inspections
• Selection, Installation and Attributes of Ideal Pharmacovigilance Software
• Pharmacoepidemiology: Applications and Current Relevance to India

All attendees will receive a DIA Certificate of Attendance at the conclusion of the event.

Venue: Taj Mount Road, Chennai, India

Contact:
DIA (India) Private Limited,
A-303, Wellington Business Park I,
Andheri-Kurla Road, Marol, Andheri (East), Mumbai 400 059 India
Phone: +91-22-6765-3226
Fax: +91-22-28594762

National Seminar on Formulation Strategies for Ayurveda, Unani & Siddha Medicinal Products

Industry Institute Partnership Cell (IIPC) & Bombay College of Pharmacy has organized a Seminar on "Formulation Strategies for Ayurveda, Unani & Siddha medicinal products: Recent Trends & Advances" on February 20, 2010

This seminar aims to highlight the recent trends and advances in the development and regulatory trends of traditional medicines.

Only 70 registrations on “First come first served Basis"

Registration Fees:
Rs. 1000/ for Corporate
Rs. 500/ for Academia
Rs. 250/ for Students

Contact:
Mr.Ashish Kshatriya,
Research Scholar,
Department of Pharmacology,
Bombay College of Pharmacy,
Kalina,
Mumbai – 400098
Contact No. +919769619707
E-mail ID: ashishbcp@gmail.com
mnsarafstudents@gmail.com

New Diagnosis for Diabetes

The American Association of Clinical Endocrinologists (AACE) today has approved the use of A1c as an additional diagnostic criterion for type 2 diabetes. An A1c of 6.5 or greater is now considered an alternate criterion for the diagnosis of type 2 diabetes.

The decision was announced in a position statement entitled “The AACE/ACE Statement on the Use of A1c for the Diagnosis of Diabetes.” The position statement can be found online here. The position statement also reviews the limitations of the test. For example, certain ethnic groups may have marginally elevated values which do not necessarily indicate diabetes.

The rationale for the use of A1c for diagnosis is based on data showing that retinopathy occurs in
individuals with an A1c ≥6.5% at approximately the same rate as in individuals who are diagnosed based on the current fasting and post-challenge glucose criteria. A 10% risk for retinopathy has historically served as the bench mark for diagnosing the presence of diabetes.

Advantages of this new diagnosis:

• Does not require the patient t be fasting
• Can be done at any time that a visit is scheduled
• Simpler to perform than the 2 hr oral glucose test
• Less dependent on the patient’s health status at the moment of the blood draw.

The most common criteria currently used to diagnose diabetes are a fasting glucose of 126 or greater or a 2 hour value on a glucose tolerance test (GTT) greater than 200. Both tests require patients to fast for a minimum of eight hours prior to being tested. The GTT is a 2 hour series of glucose levels following the administration of a large amount of glucose.

The AACE Guidelines for the Management of Diabetes (link) use A1c of 6.5 or less as a goal for patients once they have been diagnosed with type 2 diabetes.

Indian Herbal Conference to be held in Chennai on Feb 13,14.

Indian Herbal Conference scheduled to be held in Chennai on February 13 and 14 under the patronage of Cholayil Ayurvedic Health and Research Academy will focus on present problems encountered by the medicinal plant manufacturers, plant growers, collectors and herbal drug manufacturers.This conference will also suggest a concrete solution on how to preserve and conserve the traditional medicinal plant materials without losing its natural quality, said Dr VP Siddhan, chairman of Cholayil Ayurvedic Group and President of the herbal conference-2010.

He said even though Cholayil Group is organizing the conference in the name of Herbs for the first time, it has conducted five other national and international conferences on Ayurveda and Indian Medicines in the past. In the beginning, in the year 2000 it was held in Chennai, but in later years the conferences were conducted in Hyderabad, Vijaywada, Bangalore and New Delhi.This time the theme of the two days conference is "preserve our natural medicines".

The theme of the previous conferences was disease oriented, but this year it is based on herbs as the country is losing a good variety of raw drugs which will affect the industry also. The conference will honour two herbal growers for their outstanding contribution to medicinal plant conservation. It will provide educational opportunities for pharmacists, pharmacognosists, botanists, ethno botanists, ethno pharmacologists, plant growers and others involved in research, evaluation, development and marketing of botanicals for use in health care.

A pre conference workshop is also planned on February 12 at Cholayil medicinal plants Conservation Park at Vengalpuram near Chennai with a participation of about 1000 delegates. The participants will get an opportunity to visit the farm spread over an area of 120 acres with more than 1000 species of medicinal herbs, shrubs and trees. Live demonstration of HPTLC (high performance thin layer chromatography) finger printing of chemical constituents of the herbs, isolation methods of chemicals from plants using various extraction procedures, identification herbs by its morphological and anatomical characteristics are arranged in the workshop.

The importance of organic farming also will be demonstrated in the workshop.Retired chief conservator of Tamil Nadu, CK Sreedharan will deliver the keynote address. Dr. GG Gangadharan from FRC HT, Bangalore will inaugurate the conference.

GSK may cut up to 4,000 jobs

Reports suggest that GlaxoSmithKline (GSK) will announce major job cuts later this week as part of a renewed cost reduction drive. According to the Sunday Times GSK will unveil the 4,000 jobs losses at its results presentation later this week, along with details of its plan to grow in emerging pharmaceutical markets.

While GSK has not yet commented on the reports, the cutbacks would be in keeping with the restructuring programme the firm began in 2007 and would fit with the general industry trend that last week saw UK rival AstraZeneca announce plans to shed 8,000 jobs by 2014. Most observers suggest that, like AstraZeneca, GSK will focus the job cuts on it R&D division, in a bid to improve efficiency.

Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers

An article published in Trials Journal provides practical guidance for those involved in the publication process, by proposing a minimum standard for de-identifying datasets for the purposes of publication in a peer-reviewed biomedical journal, or sharing with other researchers. Basic advice on file preparation is provided along with procedural guidance on prospective and retrospective publication of raw data, with an emphasis on randomised controlled trials.

Guidance on following topics are discussed too

• Data preparation guidance
• Anonymisation
• Use of dates relevant to individual
• File preparation
• Copyright
• Preparing for journal submission—statement in submitted manuscript

Emergency Contraception Drug Breakthrough

New research published in The Lancet shows that French company HRA Pharma's emergency contraception drug ellaOne (ulipristal acetate) prevents more pregnancies than the widely-used alternative, levonorgestrel (marketed as Plan B, Levonelle and NorLevo in the US, UK and most of western Europe, respectively). ellaOne has recently been licensed for use up to five days after unprotected sexual intercourse, compared with just three days for levonorgestrel.The authors of the study performed their own trial, and combined their results with a previous study (meta-analysis). Combination of data from the two studies allowed analysis of a sample sufficiently large to show that, compared to levonorgestrel, ellaOne almost halved the risk of becoming pregnant in women who received emergency contraception within 120 h (five days) after sexual intercourse.

ellaOne was approved by the European Medicines Agency in May 2009 as a safe and effective method of emergency contraception for use up to five days after unprotected sexual intercourse — and is currently being launched throughout Europe. However, although it could be made available through pharmacies and via nurses, it will not be as easily accessible as levonorgestrel until more safety data become available.

The study's findings are published in Article Online First (www.thelancet.com).

NPPA recovers over Rs 35 cr in 9 months from companies for overcharging

The national drug price regulator National Pharmaceutical Pricing Authority (NPPA) has recovered more than Rs 35 crore in the first nine months of the current financial year from the companies for overcharging drug prices, as against the recovery of more than Rs 50 crore in the last fiscal.

With this, the authority has recovered nearly Rs 200 crore out of the total due amount of almost Rs 2100 crore from the pharmaceutical firms in the country, informs S M Jharwal, chairman, NPPA. However, the details of the firms which had paid the overcharging dues is yet to be known.

According to the information furnished by the NPPA with the panel, earlier in 2009, the total number of cases also includes 76 cases where the demand has been contested by the company in courts of law and 14 cases referred to collector concerned for recovery but subsequently contested by the companies in courts of law.

Two-day clinic on “Meeting the Inventor”

The Academy of Intellectual Property Studies (AIPS) will be organizing a two- day clinic on “Meeting the Inventor” on February 12 and 13.

The clinic will be an in-depth analysis of the interaction between the inventor and the IP cell in an organization. In an effort to maximize the IP value of the R&D efforts of the organization, especially that of the patents it files, the patent has to stand in the court of law and also have the best achievable commercial value. To ensure this, the patent manager / attorney and the actual inventor have to work in tandem, such that the groundwork laid is dependable and foolproof. The clinic is devised to develop related expertise, and looks at how the IP cell and the R& D team in an organization should interact such that potential IP is recognized and its full value extracted.

The clinic will adopt a highly interactive methodology .Under the mentorship of experienced professionals, a real-life scenario will be simulated wherein the participants will work on suitable cases.The AIPS clinic will train participants with the support of leading faculty H. Subramaniam of Subramaniam, Natraj & Associates, New Delhi and Dr B N Roy of Lupin Ltd.

For more details e-mail info@aips.ac.in or gita@aips.ac.in

DCGI office not empowered to issue CoPP under D&C Act, TNDCOA

The Tamil Nadu Drug Control Officers Association (TNDCOA), which in October last year had challenged the DCGI order relating to centralisation of CoPP in Madras High Court, has contended in the court that the DCGI office (CDSCO) has the power to grant licences to only three items such as blood & blood products, intravenous fluids and sera & vaccine.

In its reply affidavit to the Madras High Court, which is hearing the CoPP case, the TNDCOA said that as per the amendment in the Drugs & Cosmetics Acts & Rules in 1992, the CDSCO has the power to grant licences only for three items such as blood & blood products, intravenous fluids and sera & vaccine.However, in the year 2005, 10 medical devices have also been included under Rule 68 (A) of the Act.

The CDSCO stands as approving authority only for these few items of drugs as defined under Rule 68 (A), the affidavit said. The association in its reply affidavit clarifies that the issuance of CoPP under WHO certification scheme is not a statutory function governed by Drugs & Cosmetics Act of 1940 and Rules of 1945. But it has informed the court that the state drug controlling authorities, being licensing authorities as per the law, are competent to issue the CoPP and they alone can satisfy the requirements of WHO regulations.

According to them, the state drug controlling authorities are the competent persons to be certifying authority under WHO certification scheme as per the requisite criteria stated therein considering the provisions of D&C Act and rules. Under the provisions of the Act, the state drug controlling authorities have been notified as licensing authorities to grant or renew license for manufacture or sale or distribution of drugs. The reply affidavit says that the statement in the counter Affidavit filed by the CDSCO Chennai office that the WHO empowers only National Regulatory Authority of a country as the competent authority to issue CoPP, is incorrect and misleading. It also said there are separate definitions in the WHO guidelines on ‘Competent authority’ and ‘Certifying authority’. The affidavit says that the claims of CDSCO as it is the National Regulatory Authority is factually incorrect because there is no such NRA constituted under the Act.

In the year 1977, the Ministry of Health and Family Welfare of the Government of India decided that India should participate in the Certification Scheme of the quality of Pharmaceutical products moving in international commerce and accordingly the WHO was informed. Considering the fact that the state governments are responsible for issuing licences to drug manufacturers and for ensuring that the manufacturers adhere to the prescribed standards, the WHO was informed that drug controllers in the various states in India would be the competent authority to issue necessary certificate for pharmaceutical products manufactured in their respective states and which are exported out of India.

Further it said that the DCGI was usurping the powers vested with the state drug controlling officers by attempting to centralize the WHO GMP Certification and his decision was illegal. They also alleged that the minutes of the Drugs Consultative Committee (DCC) held in 1995 and in 1998 were not correctly reported in the counter affidavit filed by the counter petitioner. In the DCC meetings, the views expressed by state drug controllers were recorded and accordingly it was left to the state licensing authorities to issue the certificates.Meanwhile, the case of issuance of CoPP is still continuing in the Madras High Court for a final verdict and it will come up again for hearing on February 1.

Clinical Establishments (Registration & Regulation) Bill gets Cabinet nod

the much-delayed ‘Clinical Establishments (Registration and Regulation) Bill' will be introduced in the budget session of Parliament as the Centre has approved the proposal of the Union Health Ministry in this regard. The Bill, which has been pending for several years, aims to bring in uniformity in the healthcare delivery sector by making the registration of all clinical establishments mandatory and prescribing enhanced penalty for the defaulters. The next session of Parliament is expected to commence in the last week of February.

The Union cabinet in its meeting recently has approved the proposal of the health ministry for the introduction of the Bill in order to achieve the mandate of Article 47 of the Constitution for improvement in public health. Once the Bill gets the approval of Parliament, initially the law will come into effect in the states of Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and all union territories. It is expected that other states would also adopt this legislation later.The Bill was to be introduced in the last session of Parliament and in fact it was also included in the legislative business prepared for the last session, but the health ministry could not complete the procedures for the introduction of the Bill.

The main purpose of the law is to provide a legislative framework for the registration and regulation of clinical establishments in the country and also seeks to improve the quality of health services through the National Council for Standards by prescribing minimum standards of facilities and services which may be provided by them. This would permit categorization and classification of different clinical establishments depending on their geographical location as well as services offered. It will also initiate the process for the creation of a national registry of clinical establishments existing in the country.

Even though several states have already enacted laws for regulating health care providers, the general perception is that current regulatory process for healthcare providers in India is inadequate or not responsive to ensure health care services of acceptable quality and prevent negligence.

Presenlty, the supervision and regulation of the quality of services provided by the health care delivery system to the people by both public and private sectors has largely remained a contentious matter and therefore, unresolved issue. The current structure of the healthcare delivery system does not provide enough incentives for improvement in efficiency. The private sector health care delivery system in India has remained largely unregulated and uncontrolled. Problems range from inadequate and inappropriate treatment, excessive use of higher technologies, wastage of scarce resources and problems of medical malpractice and negligence.

Once the law comes into effect, all the clinical establishments in the country have to follow the mandatory registration. As per the Bill, clinical establishment would include hospitals, maternity home, nursing home, dispensary, clinics and similar facilities with beds that offer diagnosis, treatment or care for illness or injury or pregnancy in any recognised system of medicine (Allopathy, Yoga, Naturopathy, Ayurveda, Homoeopathy, Siddha and Unani). It also includes any laboratory (either established as independent entity or part of an establishment) which offers pathological, bacteriological, genetic, radiological, chemical, biological and other diagnostic or investigative services. Furthermore, the establishment can be owned by the government or department of the government, a Trust (public or private), a corporation (including a cooperative society), a local authority and a single doctor establishment.