Clinical Establishment Bill passed in the Lok Sabha

With the passage of the much awaited Clinical Establishments Bill, 2010 in the Lok Sabha, it has become mandatory that all the clinical establishments in the country, big or small, should be duly registered as per the provisions of the Bill.

The Bill, which was pending for several years, aims to bring in uniformity in the healthcare delivery sector and prescribes enhanced penalty for the defaulters.

The proposed legislation is applicable to all the clinical establishments under all recognized systems of medicines or treatment such as Allopathy and Ayush. Another important aspect of the legislation is that it would apply to all the hospitals or clinics including single doctor establishments, with or without beds.

The legislation also makes it obligatory that any doctor in a registered clinic, hospital or other clinical establishment must provide treatment to anyone who is brought in an emergency medical condition. The patients cannot be sent back on excuses.

The Bill proposes a multi member National Council for clinical establishments to classify, determine and develop standards of clinical establishments and also to compile and publish national register of such establishments.

It also mandates that every State would set up a multi-member State Council of Clinical Establishments soon. In the states, the Registering Authority for Clinical Establishments would be a multi-member body at district level. The registration would be of two types, provisional and permanent. Permanent Registration would be provided after standards have been notified. There are different standards for different categories of clinical establishments.

The Bill says all the transactions under the proposed law would be transparent and in the public domain. The state register will help for the creation of a national database. Appeals against the orders of the Registering Authority shall lie to the State Council of Clinical Establishments.

The legislation would also empower the State Government or Registering Authority to direct any or all clinical establishments to furnish such returns/statistics or other information as may be required.

SMS based IT solution to track expired drugs

A north based IT company, Pharma Secure has come out a high-end technology solution system to tackle the expired drugs concerns amongst the consumers. The solution provides the consumer with a short message on the mobile phones. The company claims that it is the first technology solutions to track the expired drugs.

The novel solution can track expired drugs with SMS and gives the consumer a short narrative about the status of the drug, whether it is time barred or spurious or sub-standard or banned one, along with a warning to the user to contact his/her chemist for more information.

The director-sales of Pharma Secure, Kishore Kar explained to the traders and manufacturers of Tamil Nadu pharmaceutical industry about the service and operation modes at the IPA sponsored symposium. Even though, the solution is mainly useful for the importers, the company was targeting all the stake holders of the industry including retailers and end users.

The company does not rule out the possibility of recycling expired drugs by some anti-social elements. Circulation of such drugs in the market not only harm the consumers, but also tarnish the image and long-term revenue potential of domestic pharma manufacturers. Often the drug regulators are unable to track all the sources of expired drugs, but a solution like SMS based tracking should help both the regulators and the customers.

“We are offering low cost, scalable and secure services for the manufacturers of and customers in Tamil Nadu and in other states. Our modules are the most targeted solutions for addressing the sale of expired drugs. The basis of these solutions lies in attributing a unique identifier code on drug packing, and associating these with authentic manufacture data, for instance expiry date”, he said.

Once a drug reaches the hands of the end user, the consumer can send one SMS indicating the code to Pharma Secure’s national authentication line, which promptly returns a valid, invalid or over-verified response. Authentication about expired drugs, validity of origin, product specific information and market data are given through this service. With its focus on the Indian Pharmaceutical sector, Pharma Secure is planning to partner with manufacturing companies shortly.

FOPE demands extension of two years before implementing the new Schedule L-1

The Federation of Pharma Entrepreneurs (FOPE) has urged the central government to give an extension of two years before implementing the new Schedule L-I of Rules 74, 78 and 150 E. It stressed that since the small and medium enterprises (SMEs) are yet to come to terms with the concept, they should be given some time to accept the impending changes.

As per the union health ministry's notification, all the pharma companies in the country have to adhere to the new GLP regulations under Schedule L-I of Rules 74, 78 and 150 E under Drugs and Cosmetics Act by November 1, 2010. Under the new regulations, pharma companies will need to have the necessary requirement of premises and equipment along with upgradation of their systems.

FOPE pointed out that it is strongly felt in the SME segment that there is a lot of gap between current practice and newer GLP norms. Apart from that there is also shortage of trained QC and QA personal to handle the change.

This issue was discussed by FOPE at a one-day pharmaceutical convention organised by FOPE along with Himachal Drug Manufacturers Association (HDMA) recently at Solan district, Himachal Pradesh. The conference aimed to deliberate on various issues in the common interest of all manufacturers and was attended by almost 250 people from the industry.

It was decided that a committee shall be set up under Vinod Kalani, general secretary, FOPE; Jetendra Kumar, vice president, operation QA, Mankind Pharma; Arun Kumar, Medicamen Biotech and Rajeev Saxena who shall study the GLP document. Once they study it, they plan to discuss the fine points with other professional bodies like IDMA, IPA to identify the operational problems with the new GLP.

The occasion was also utilised to discuss other major issues of the pharma industry. FOPE raised the issue of exemption to SSI which was denied because many units could not file declaration of SSI status within 60 days of start of the production. S M Jharwal, chairman NPPA, assured that they would consider the matter. It was told that the price difference demands against the SME’s are negligible if compared to total demand pending against the industry.

The Health Minister of Himachal Pradesh Rajiv Bindal in his speech appreciated the efforts taken by technocrats to establish state of art facilities in the state of Himachal Pradesh and assured all help and support to units manufacturing good quality products.

B R Sikri, co-chairman, FOPE narrated the initiatives taken by FOPE for resolving various issues of industries based at Himachal Pradesh and Uttrakhand excise free zones specifically.

5th Amendment of D&C Rules 2010 for Ayush drugs

Union Govt. has issued a draft copy of the Drugs and Cosmetics (Fifth Amendment) Rules 2010 for the Ayush industry seeking to introduce licensing for production of herbal formulations. The new rules would be issued under section 33 N of the Drugs and Cosmetics Act 1940.

The fresh rules are for Ayurveda, Unani and Siddha drug manufacturers under section 3 (A), ‘Balya, Poshak, Muqawi and Unavuporutkal’ which are positive health promoter formulations having ingredients mentioned in the books of the First Schedule of the D&C Act and recommended for promoting and preventive health. The formulations under Saundarya Prasadak and Azhagh-sadan having ingredients recommended for oral, skin, hair and body are also provided with a set of procedures for production.

In a communique from the Ministry of Health and Family Welfare, Department of Ayush, via GSR 377(E) No. K11020/02/2010 DCC Ayush, comments were sought from the industry on the draft before the end of June, 2010. The rules will be finalized then and will be approved for publication in the Gazette.

The new set of rules will be introduced after Rule 158(A) as 158(B) of the Drugs and Cosmetics Act 1940.

According to the draft, the drugs for Ayurveda, Unani and Siddha will not require data submission on safety study and evidence of effectiveness but the use of ingredients should be according to Indian system of medicine texts.

For the issue of licenses for patent and proprietary drugs, safety study report is not required but manufacturers will need to submit a pilot study according to the protocol of Ayurveda, Siddha and Unani drugs.

For the Medicines prepared using ingredients listed in Schedule E (1) of the Drugs and Cosmetics Act, 1940, companies will need to furnish the safety data and proof of effectiveness.

Govt. of India facilitating the export and import of drugs through Airports

As part of the efforts to improve the situation in the airports to better handle the exports and imports of drugs, the facilities at some leading airports are being augmented, though the original plan to create special pharma zones is yet to be implemented formally.

The government is taking steps following the complaints from the industry that the quality of medicines transported through air routes is getting affected due to lack of proper storage system at airports. Efforts are on by some of the agencies running the airports to augment their facilities as the storage facilities are either maintained by the airport authorities or the airlines.

Mumbai International Airport Pvt Ltd (MIAL) has already created four new cold rooms for pharma products. The Delhi International Airport Limited (DIAL) has also planned to create 3700 square meters of additional cold room facilities for pharma products when the new cargo terminal becomes operational, sources said.

Drugs when not stored at recommended temperature whether transported through air route or any other mode of transport can deteriorate due to extreme temperatures, both high and low. Facilities for storage of drugs, including drugs requiring special storage conditions, are available at some of the airports. Where such facilities are not available because of space constraints or other reasons the consignments requiring special storage conditions are released on priority basis to avoid any deterioration in the quality, sources said.

The CDSCO had suggested creation of dedicated pharma zones at the airports and seaports in line with good manufacturing practices and good distribution practices to assure quality, safety and efficacy of drugs meant for export and import. However, it is yet to be officially launched.

As per the plan, pharma zones are to come up at the airports of Delhi, Hyderabad and Mumbai. Besides, another cargo zone will come up at Nhava Sheva port at Navi Mumbai. The DCGI office also had already initiated consultations with the airport developers and the civil aviation ministry in this regard.

The 62nd Indian Pharmaceutical Congress will be held in Manipal

The 62nd Indian Pharmaceutical Congress (IPC), hosted by Indian Hospital Pharmacists’ Association (IHPA), will be held from December 17 to 19, 2010 in Manipal University.

It was at the 61st edition of the Indian Pharmaceutical Congress Association (IPCA) at Ahmedabad in December 2009 that the announcement was made. This event is taking place in Manipal for the third time.

The IPC is organized every year by IPCA, which is a federation of five professional bodies, viz., Indian Pharmaceutical Association (IPA), Indian Pharmaceutical Graduates’ Association (IPGA), Indian Hospital Pharmacists’ Association (IHPA), Association of Pharmaceutical Teachers’ of India (APTI) and All India Drugs Control Officers' Confederation (AIDCOC).

The 62nd Indian Pharmaceutical Congress will be held at Manipal in Karnataka. It will be held under the aegis of the Indian Hospital Pharmacists' Association (IHPA). As the president of the host association, I have great pleasure in inviting all pharmacists- regulatory, teachers, researchers and industrialists & students to the three-day event. One can look forward to this event in a rather serene atmosphere of Manipal, a small town known for high standards of professional education and human endeavour.

IHPA is a professional body of practicing pharmacists in the country. The practice of pharmacy has seen tremendous changes in the recent years. In the West the pharmacists play stellar roles along with doctors and nurses in health care delivery. The conditions in India up to now have not been satisfactory for the pharmacists. Except in rare instances, the pharmacists in India play only passive role in patient care. It is this lacuna that IHPA is trying to address. The IHPA aims to secure for them their rightful place through more active involvement in pharmaceutical care. They must strive for excellence and status in the society. Professional ethics must be maintained. For assuming the new responsibilities, they should gain more knowledge and develop skills.

Important Dates

Online Submission Starting from: 1st August 2010

Last Date for Online Submission: 30th September 2010

Announcement of Acceptance: 15th October 2010

Pharma Export Council to open offices abroad

The Pharmaceutical Exports Promotion Council (Pharmexcil) will soon start offices and warehouses in the US, Europe, Latin America and Japan to help Indian drug exporters boost their business in markets abroad. Pharmexcil, under the Ministry of Commerce, is working out a detailed strategy paper in this regard, said Smitesh Shah, chairman.

“These four markets constitute a majority of exports by our members (over 1,500) and the move is to help in market development and to bring down export costs by using common warehousing facilities and office infrastructure, especially for companies entering into newer geographies,” he said.

Six-year-old Pharmexcil has regional offices in Mumbai, New Delhi and Ahmedabad, besides headquarters in Hyderabad.

Shah said though pharmaceutical exports were down in the April to October period of 2009, recent trends showed these had picked up. A temporary slowing was mainly due to the global slowdown in 2008-09 period, which resulted in less orders from overseas wholesalers to clear their inventories and less than expected orders from multinational companies for contract manufacturing.

The growth in drug exports from India decreased to about 10-12 per cent in the first three quarters of 2009-10, in comparison to Rs 39,537.7 crore of exports, with a 29 per cent growth, recorded in 2008-09, showed data from the Directorate General of Commercial Intelligence & Statistics (DGCI&S) and the Centre for Monitoring Indian Economy (CMIE). India’s drug exports grew at an average rate of 21 per cent in the past four years.

Shah said India’s drug exports were likely to show above 15 per cent growth for 2009-10. India’s $12-billion (Rs 53,500 crore) pharmaceutical industry earns 40 per cent of its revenue from exports of off-patent generic drugs.

A CII-KPMG report estimates total Indian pharma output (including that for export markets) would be growing at a compounded annual rate of 16 per cent over 2007-11. According to a Mckinsey report, the domestic pharmaceutical market is set to grow from $6.3 billion (Rs 28,000 crore) in 2005 to $20 billion (Rs 89,000 crore) by 2015, with a growth rate of 12.3 per cent.

Tighter norms for Clinical Research

The government will soon make it mandatory for all firms involved in clinical research to maintain minimum quality standards and register themselves with the country’s drug regulator, a health ministry official said.

Once the law is implemented, the names of all the approved clinical research organisations (CROs) in the country will be uploaded on the website of Drug Controller General of India (DCGI). A violation of the norms could lead to the firm being barred from conducting clinical studies in India.

“It will weed out fly-by-night CROs,” said the official requesting anonymity. The health ministry will notify the amendment soon and the government inspectors then will start random audits to ensure the requisite standards are maintained, he said.

Several inspectors at the DCGI have been trained by the US Foods and Drug Administration to audit CROs.

The country’s highest technical body on medicines, Drug Technical Advisory Board, has approved an amendment to the Drugs and Cosmetics Act to make CRO registrations compulsory.

According to consultancy firm KPMG’s pharma analyst Hitesh Gajaria, the move is a step in the right direction but it must be effectively implemented. “This will regulate the entire clinical protocols, ethical norms and other practises,” he said. At present, there are 40-50 CROs in the country, a number that is increasing steadily.

CROs typically provide research services to drug companies in developing medicines, especially the clinical trials. They also liaison with hundreds of hospitals and clinics in the country who conduct clinical trials for Indian and global pharma companies.

India’s clinical research market is estimated at $300 million and growing at over 30% annually, thanks to the diversified gene pool and lower cost of clinical studies compared to developed markets. Although, Indian CROs are regarded highly in the global pharma industry, the local industry has remained largely unregulated.

Social groups have also occasionally raised concern about mandatory protocols not being followed during clinical trials and Indian patients being used as cheap targets.

The government’s move comes within weeks of Parliament passing the Clinical Establishments Bill, 2010 making registrations of all clinical establishments in the country, such as hospitals and clinics, mandatory.

Pharmacovigilance Programme to start on July 1st with 10 medical colleges in 1st phase

The much awaited National Pharmacovigilance Programme, is expected to begin in 10 medical colleges across the country from July 1 this year. The first phase of the programme will be launched in 10 of the 300 medical colleges in the country and the DCGI plans to further extend it to 40 other colleges by next year and 60 the next. DCGI said that by 2014, all the 300 medical colleges will be participating in the National Pharmacovigilance Programme.

The national level Pharmacovigilance Programme will have a two pronged approach and will be targeted for five years initially. In the budgetary provisions the pharmacovigilance programme was granted with Rs 85 Lakh against the expectation of Rs 1.5 crore. This programme was supposed to be launched earlier in the month of April but it had repeatedly got delayed due to problems in the Union Health Ministry. The DCGI expressed that funding is the most important aspect right now for the success and development of this programme. Almost 50% of the allotted money will be used on HR to increase the manpower since it’s an issue that’s been haunting the DCGI’s office from the past several years.

The programme will be run in three units that comprises of the medical colleges, other institutes and CDSCO. AIIMS will act as the main centre for the National Pharmacovigilance Programme, whereas the CDSCO will be providing funds, manpower, training etc to the AIIMS and other institutes involved in this programme. This programme will be started in 10 medical colleges this year.

IDMA urges govt to include Pharmacovigilance in Medical and Pharmacy syllabus

The Indian Drug Manufacturers' Association (IDMA) has urged the union health ministry to include pharmacovigilance as a topic in the subsection of pharmacology in the syllabus of medical and pharmacy students in the country.

In a White Paper recently submitted to Drug Controller General of India (DCGI) Dr Surinder Singh, the IDMA said that including pharmacovigilance in the syllabus will enable the medical and pharmacy students to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug reactions (ADRs), the manner in which these are detected and monitored, and the related historic and legal frameworks etc.

Spontaneous reporting of ADRs is an important method for detecting new safety issues related to drugs and the best way to increase reporting is by way of educating students, the IDMA said and added that since pharmacovigilance is the best tool to indicate the safety of a drug, its awareness and understanding, must be ensured at all stages for all those associated with the drug industry.

There is an increasing need for well informed professionals to work in all areas related to the assessment of drug safety and risk-benefit of drug use. IDMA stressed on the need for implementing new rules so that it could strengthen the existing pharmacovigilane system in the country. Thus education on pharmacoviligance and importance of reporting should be extensively incorporated into medical and pharmacy training to address these issues.

The white paper also focussed on other issues pertaining to industry and laid down suggestions to the authority to ponder on. IDMA stressed that the pharma companies and CRO's must understand and support the need to have an adverse drug reaction registry database at CDSCO.

The white paper suggested that there should be a system devised of analysing ADR drug wise devised by the pharmacovigilance department of the CDSCO and the outcome should be published preferably bi-annually as report to the nation besides forwarding the same to the medical associations.

The paper calls upon practising medical professional to report ADRs and professional associations to be entrusted with task of taking suitable steps to ensure the same. It stresses that guidelines for reporting ADRs by the healthcare professionals should be accessible wherever reporting forms are available.

Indian Pharmacopoeia 2010 to be released soon

Indian Pharmacopoeia Commission (IPC) is going to release the Indian Pharmacopoeia (IP) 2010 - Sixth Edition, which is in print, in few months. IPC, under the Union Ministry of Health has now started working on the Addendum to IP 2010, as decided in its Scientific Body’s meeting held in May.

At present the Indian Pharmacopoeia does not have much provisions relating to excipients and IPC has recognised the need, which has triggered this move. “One of the important areas that IPC has decided to work on is to strengthen the quality standards for excipients. “The IP 2010 edition thus will have twenty one new monographs on excipients and the addendum is going to focus further on this critical area,” informed Dr D B A Narayana, member of the Scientific Body, Indian Pharmacopoeia Commission.

In a meeting held in Delhi on May 1 it was decided by the IPC to address this in the addendum. Speaking about this Dr Narayana, said that work on the addendum has already begun. He averred, “It is important to focus on excipients and its quality since any compromise on the same can adversely impact the stability of the drugs.”

In India excipients are largely imported and some of the excipients are manufactured within India. The excipients that are imported are tested according to the pharmacopoeia of the country manufacturing it. At present, the Indian Pharmacopoeia does not specifically address this segment fully, thus the pharmacopoeia commission felt the need to review and prepare new monographs and add it accordingly.

According to Dr Narayana, once the addendum work starts, the excipients that are imported in large quantities need to be looked into. Similarly, those excipients that are known to be more critical for quality will also need to be assessed. He said, “The pharma companies are required to inform the pharmacopoeia commission about the excipients manufactured in India, and about those that have no IP monograph.” The pharmacopoeia wants the stake holders to work with the commission so that they can keep a better tab on the quality of the drug.

The Indian Pharmacopoeia is the official book of standards and medicines produced in India, and the companies must comply with the specified quality standards. Pharmacopoeial standards and acceptance criteria are set with the intention that they be used only as compliance requirements and not as requirements to guarantee total quality assurance. The main aim is to promote public health in India by bringing out authoritative and officially accepted standards for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers. The Indian Pharmacopoeia Commission (IPC) has been formed as an autonomous institution under the Ministry of Health and Family Welfare’s on 2008. It is dedicated for setting of standards for drugs, pharmaceuticals and health care devices/technologies etc besides providing reference substances and training.