You are browsing the archive for 2010 September.

Avatar of admin

by admin

DCGI linking State drug control units, labs under national network

September 30, 2010 in DRUGS CONTROL

As part of strengthening the drugs control organisation in the country by implementing the e-governance, a comprehensive computerisation programme by linking all States drug control units, CDSCO zonal offices with the office of the Drugs Controller General of India (DCGI) has been launched and is nearing completion.

The country-wide networking, launched by the CDSCO, will also connect the laboratories under the Central government and the State governments, apart from the State units and CDSCO offices, through the IT-enabled services with a view to making the whole drug control administration more transparent and effective. The networking is expected to be over by the end of this year, sources indicated.

Sources said the drug control organisation is being comprehensively strengthened. All vacant posts in CDSCO are being filled up on fast track basis. 216 new posts in various grades including 137 posts of drugs inspectors have been created and are being filled up. Besides, 250 personnel at various levels are being appointed on contractual basis.

“A massive regulatory capacity building exercise has been undertaken with the help of WHO, Health- Canada and US FDA. National Pharmacovigilance Programme is being restructured and strengthened. Draft Guidelines on Regulation of Medical Devices have been issued. An expert Committee under the chairpersonship of the Secretary (Health & Family Welfare) has been set up to go into all aspects of the medical device regulations,’’ an official of the health ministry said while detailing the different efforts to further bolster the entire system.

The target of the DCGI was to depute at least 200 drug inspectors by the end of this year and the efforts in this regard were right on the track with fast track clearance from the ministry. The state governments have also been asked to strengthen the infrastructure by inducting more number of inspectors and upgrading the facilities for testing samples. There are six central drug testing laboratories and another 72 labs in the States.

Tags: , No Comments »

Avatar of admin

by admin

Jan Aushadhi stores start sourcing medicines from open market at higher prices

September 30, 2010 in pharma industry

Even as the Department of Pharmaceuticals (DoP) is still toying with the idea of sourcing the generic medicines from private companies for the Jan Aushadhi stores, some of the Jan Aushadhi stores have already started sourcing medicines from open market as the public sector pharma units are not able to supply enough drugs to these stores, resulting high prices of these drugs.

The prices of medicines sourced through open market are much higher than the prices being quoted in Jan Aushadhi stores, which was launched to ensure that essential medicines are made available to the vast majority of common people in the country at affordable prices.

According to sources, the Jan Aushadhi store in Amritsar in Punjab, the first Jan Aushadhi store in the country that was inaugurated by the then union chemicals minister Ramvilas Paswan in November 2008, is not getting the enough quantity of drugs from the public sector pharma companies like IDPL, RDPL, etc for its sales and has started sourcing the drugs from open market at high prices.

Sources said that the main reason for this development is the totally indifferent attitude of the senior officials in the DoP towards the Jan Aushadhi Project, which the union minister of state for chemicals and fertilisers, Srikant Jena wanted to make a national movement to ensure that essential medicines are made affordable and accessible to the common man of the country. Even after shortlisting several private companies for sourcing the medicines at much cheaper rates, the DoP did not start sourcing from them even after almost two years of the launch of the project.

For sourcing the drugs from private companies, the DoP had invited expression of interest from the companies in December 2008 and a large number of private companies, including some big companies, were shortlisted by the department. But after scrutiny of the applications and the physical inspections of the premises of some of the applicants, the DoP finally cancelled the entire process, which was not revived so far for reasons best known to the DoP only.

Interestingly, the small drug units had offered to supply the generic drugs at much cheaper rates than the market rates. In most of the cases, the prices of generic drugs, quoted by the small companies, are just one-fourth of the prevailing market rate of the generic medicines. But, all the pleas of these companies fell on the deaf ears of the DoP, sources said.

Tags: No Comments »

Avatar of bhupendra

by bhupendra

Directors can be prosecuted for fungus loaded drugs: SC

September 28, 2010 in pharma industry

Directors of pharmaceutical companies are liable for criminal prosecution in the event of the company being found responsible for manufacturing defective drugs as it would seriously affect public health, the Supreme Court has ruled.

A Bench of Justices V S Sirpurkar and Cyriac Joseph passed the ruling in a judgement while dismissing the appeal filed by directors of a Gujarat-based drug company challenging their prosecution for supply of fungus-loaded drugs.

The apex court rejected the argument that they cannot be prosecuted as the complaint lodged against them by the State Government contained “bald statements” and no direct allegations against their involvement.

“This was the case of the manufacture of the drug for human consumption and, after it was tested in laboratory, was found to be defective since there was a growth of fungus, which is a very serious matter related to public health.

“Under the peculiar circumstances of this case and realising the seriousness of the allegations, we would not take a technical view based on pleadings in the complaint,” Justice Sirpurkar writing the judgement observed.

The apex court passed the judgement while dismissing the appeal filed by Dinesh B Patel and certain other directors of M/s. Denis Chem Lab. Ltd., Chhatral, Ta. Kalol, District Gandhinagar, against whom the Gujarat Government launched criminal prosecution under Section 34(2) of the Drugs & Cosmetics Act, 1940.

The accused had moved the apex court after the High Court dismissed their plea for quashing of the criminal cases and held that the directors are responsible for the affairs of the company and, therefore, when a drug manufactured by the company was found to be defective, all the directors could be prosecuted.

The apex court rejected the argument of the accused that just as under the Negotiable Instruments Act (cheque bounce cases) the specific role of the directors should be established before launching the prosecution against them, similar view should be taken in their case too.

“We cannot agree. Firstly, the language of Section 34(2)of the Act substantially differs from the language of Section 141 of the Negotiable Instruments Act.

“Secondly, here we are dealing with the offence which has the direct impact on the public health. We, therefore, would choose not to interfere with the order of the High Court. It will be open for the directors to show to the trial court that they had nothing to do with the manufacture process and, therefore, they should not be held liable under Section 34 (2) of the Act,” the apex court said while dismissing the appeal.

No Comments »

Avatar of admin

by admin

Temperature Maintenance in Pharmacy and Pharmacy Store

September 23, 2010 in orders

To,

The All Medical Superintendents,
Of ESIC Hospitals / Dir(Med) Delhi & Noida,
All SSMCs / SMCs.

Sub:- Regarding temperature maintained in Pharmacy /Pharmacy st9re.

Sir I Madam,

As per Drugs and Cosmetic Act-1948, storage area for medicines should have proper ventilation and should be free from dampness. In schedule P of Drug & cosmetics Act, which deals with life period of drugs, the conditions of storage are as follows»
1. Antibiotics/injections/syrups/vitamins should be stored in a cool place having temperature between 10-25 deg. C.
2. Sera toxins and toxoid, other vaccines, anti-toxins should be stored in cold place i.e. a place having a temperature not exceeding 8 deg. C.
3. Capsules should be kept in a closed container at temperature not exceeding so deg. C.
4. where conditions of storage is not specified, it may be stored under normal room temperature.

Keeping in view the above provisions in drug & cosmetic Act, 1948, it has been decided that to maintain the above temperature the Air Conditioner may be provided in the Pharmacy I Pharmacy stores (where the medicines are stored).

It is therefore, requested to take necessary action.
This issues with the approval of the Medical Commissioner.

Yours Faithfully,

Sd

AKSHAY KALA
Jt. Director (M.A.)

For detailed letter click here

Tags: , No Comments »

Avatar of admin

by admin

Govt announces bonus for non-gazetted employees

September 23, 2010 in orders

In a festival gift to non-gazetted central government employees, the Centre today announced a bonus of up to Rs 3,500 for 2009-10. All the central government employees in Group C and D and all gazetted employees in Group B who are not covered by any productivity linked bonus scheme will get bonus equivalent to 30 days emoluments, Finance Ministry said in an office memorandum.
The payment will also be admissible to the Central Police and para-military personnel and personnel of armed forces, it said. Only those employees who were in service on March 31, 2010 and have rendered at least six months of continuous service during the year 2009-2010 will be eligible for payment, it said.

Meanwhile, the Central Government also issued notification for enhancing the Dearness Allowance for its 88 lakh employees and pensioners by 10 percentage points. This comes as a follow up to the approval given last week by the union Cabinet to hike the DA from 35 per cent to 45 per cent of the basic salary of the central government employees with retrospective effect from July 1, 2010.

The increase in DA comes just a few days after the organised workforce was cheered by one percentage point increase in the interest rate on the provident fund to 9.5 per cent.

Tags: No Comments »

Avatar of admin

by admin

IPGA demands wholesale license to be issued only to registered pharmacists

September 23, 2010 in DRUGS CONTROL

The Indian Pharmacy Graduates Association (IPGA) has put up a demand with the Drug Controller General of India (DCGI) to amend the relevant provisions in the Drugs & Cosmetics Act and the Rules thereunder to mandate that only qualified registered pharmacists should be eligible for getting wholesale licence of pharmaceuticals.

At present, under the Rule 64 of the D&C Rules, 1945, the eligibility condition for issuance of wholesale licence for drugs is that a competent person, who is a registered pharmacists or who has passed the matriculation examination or its equivalent with four years experience in dealing with drugs or who holds a degree of a recognised University with one year’s experience in dealing with drugs should be in charge of the premises.

The Association argues that this leaves a quality gap in the drug distribution chain, as the competency of person involved in manufacturing is mandated to people completed science or pharmacy education and the retail licences are issued only to qualified pharmacists.

The rule was made long back, in 1945, when there were less pharmacy professionals but the scenario has changed now with more than 10,000 students completing pharmacy courses every year from almost 750 pharmacy colleges for graduation and more than 250 colleges for post graduate pharmacy courses at present, says Atul Kumar Nasa, president, IPGA.

“Since any lacuna in handling of medicines at wholesale stores can adversely affect the delivery of medicines, the D&C Act is required to be amended on urgent basis so that at all levels medicines are handled by qualified registered pharmacists only. We have raised the issue with the DCGI. The DCGI has assured that the issue will be taken up for discussion in the next DCC (Drug Consultative Committee) meeting,” said Nasa.

Similarly, the rules under the D&C Act specifying the qualification of professionals in manufacturing sites should also be amended giving due prominence to the qualified pharmacists. Pharmacists, who have completed diploma, degree or post graduate courses in pharmacy, are technically the eligible persons to handle drugs, he added.

The All India Drug Control Officers’ Confederation (AIDCOC), the organisation of drug control officers in the country, has also moved the demand to the DCGI, said Nasa, who is also the vice-president with the AIDCOC.

Tags: , No Comments »

Avatar of admin

by admin

Payment of Dearness Allowance to Centrel Government employees – Revised rates effective from 1-7-2010

September 22, 2010 in orders, Uncategorized

No. 1(6)/2010-E-II(B)
Government of India
Ministry of Finance
Department of Expenditure
——-

New Delhi,the 22nd September,2010

OFFICE MEMORANDUM


Subject:   Payment of Dearness Allowance to Centrel Government employees – Revised rates effective from 1-7-2010.

——————

The undersigned is directed to refer to this ministry’s Office Memorandum No.1(3)/2009-E-II(B) dated 26th March.2010 on the subject mentioned above and to say that the president is pleased to decide that the Dearness Allowance payable to central government employees shall be enhanced from the existing rate of 35% to 45% with effect from 1st July 2010.

2 .     The provisions contained in paras 3, 4 and 5 of this Office Memorandum No.1(3)/2008 29th August,2008 shall continue to be applicable while regulating Dearness Allowance under these orders

3.     The additional instalment of Dearness Allowance payable under these orders shall be paid in cash ro all Central Government employees.

4.    These orders shall also apply to the civilian employees paid from the Defence Services Estimates and expenditure will be chargeable to the relevant head of the Defence Services Estimates.In regard to Armed Forces Personnel and railway employees separate orders will be issued by the Ministry of Defence and Ministry of Railways, respectively.

5.     In so far the persons serving in the Indian Audit an Accounts Department are concerned, these orders issue after consultation with the Comptroller and Auditot General of India.

s/d
(Anil Sharma)
Under Secretary to the Government of India

For order click here

Tags: , No Comments »

Avatar of admin

by admin

Spurious antibiotic kills three

September 21, 2010 in DRUGS CONTROL

Three people died after being administered drugs at a primary health centre (PHC) in Suntikoppa and a government hospital in Kushalnagar, raising serious questions on the state health department’s adherence to safety standards and the quality of medicines distributed in the districts.

Five others also developed serious complications after being given medicines, including Penicillin, an antibiotic, but they survived after undergoing treatment at the intensive care unit (ICU) in a local hospital.

As news of the deaths and medicine-induced complications spread, a large number of people from Suntikoppa and its surrounding areas gathered in front of the district hospital creating fears of a breach of the peace.

But when reports of the death of Saritha, at Kushalnagar, reached the demonstrators, swarms of angry people from Madikeri, Suntikoppa and nearby areas converged on the PHC and the district hospital and demanded that the authorities immediately pay up compensation of Rs 5 lakh to the kin of those who died.

The situation was brought under control after Deputy Commissioner K H Ashwathanarayana Gowda, Zilla Parishad President V M Vijaya, ZP chief executive office A B Ibrahim and Superintendent of Police Manjunath Annigeri visited the spot. Sensing the tense situation, they contacted MLA M P Appacchu Ranjan, who was away in Bangalore.

After Ranjan contacted Health Department Secretary Dr Ramana Reddy and apprised him of the situation, a decision was taken to provide Rs 1 lakh as compensation to the relatives of the three who died – Mohideen (60), a resident of Pumphouse in Suntikoppa, Susheela (65), from Balekadu in Suntikoppa, and Saritha (35) of Kushalnagar.

The protesters withdrew their agitation after the compensation was announced. When some people objected to a local doctor conducting autopsy, K V G Medical College (Sullia) Forensics Department head Dr K B Sooryakumar was called to conduct the post-mortem.

Traffic was disrupted on the Mysore-Madikeri road between 11:30 am and 1:30 pm while vehicular movement at Kushalnagar stopped till 5:30 pm because of the agitation. The state government did not deem it fit to order an investigation, with Chief Minister B S Yeddyurappa only expressing grief over the deaths and concern for those who developed complications.

A statement issued by the chief minister’s office claimed that the deaths and the illnesses occurred because the persons developed allergy after they were administered paracemtamol injections.

It is said that Dr Tharananda, who joined duty recently at the Suntikoppa PHC, administered Paracetamol and Penicillin injections to seven persons who were suffering from headache and fever. Mohideen and Susheela collapsed as soon as they left the PHC. Minutes later, five others also collapsed.

Mohideen died on his way to the Madikeri district hospital and Susheela failed to respond to treatment. Five others were admitted to the ICU under critical condition, but survived after they were provided immediate medical attention. They have been identified as Harish (40) of Kanebail, Umar (48) of Suntikoppa, Aisamma (65) and Sandeep (27) of Gaddehalla Pumphouse, and Nabeesa (55) of Kodagarahalli.

Reacting to the incident, district surgeon Dr Ajith Kumar said that the deaths were in the category of ‘rarest of rare’, adding that the cause of death would be known only after chemical analysis of the drugs samples of which would be sent to the Drug Controller in Bangaler for examination.

No Comments »

Avatar of admin

by admin

Karnataka drugs dept involves NGOs, consumer bodies in inspection drive on pharmacies, blood banks

September 21, 2010 in DRUGS CONTROL, Uncategorized

In a major effort to reinstate its practices of transparency and stringent checks, the Karnataka drugs control department has taken a decision to rope in non-governmental organizations and consumer forums who will draw the samples of drugs for test and analysis either accompanying the enforcement officers during their random inspection drive or independently.

In this regard, the department is gearing up to draw drug samples at random from pharmacy outlets across the state. This is in a bid to assess the quality of drugs and check the sale of not-of -standard quality medicines.

The key objective is to build confidence in public and to create transparent environment and make the NGOs and consumer forums aware of the extent of the stringent checks carried out and the action taken on the violators thereafter, Dr BR Jagashetty, Karnataka drugs controller told Pharmabiz.

The department will bear the expenses of sample drive that will be carried out in all districts. Efforts are on by the team of additional drugs controller and deputy drugs controllers to plan out the mode of operation, he added.

Early this month, the drugs department had initiated a similar exercise for the 171 blood banks. It has completed the inspection of all 59 blood banks in Bangalore which had a consumer forum organization members accompany the inspectors. The surprise inspection helped to ascertain the quality standards of blood banks and availability of platelets at the 33 blood banks permitted to process blood components and stock of platelets which were found to be adequately available.

“We instructed the officers to carry out the inspection in the presence of the consumer forum. This is the first time that such an inspection was carried out, involving a third party. From the checks, stop collection orders were issued to 14 blood banks and these blood banks were not permitted to draw blood. Some banks have rectified and after another joint inspection initiative, the facilities are cleared to resume blood collection, stated Dr Jagashetty.

The remaining blood banks located across the 29 districts are being handled by the regional offices of the drugs control department at Hubli, Belgaum, Gulbarga, Mysore, Bellary and Bangalore. Each region covers around 4 to 8 districts. The inspection outcome reports will be submitted by the enforcement officials by September 27.

Following the positive response towards to inspection drive, the department was keen to extend a similar exercise for the pharmacy outlets in the presence of the NGO and Consumer Forums. Bringing in an NGO will provide transparency in practices and prevent unnecessary allegations on the service quality and drug contents related to blood banks and medicines sold in the pharmacies respectively, stated Dr Jagashetty.

The department has known to carry out regular inspections every month of production units and pharmacy outlets to uncover not of standard quality drugs and violation in manufacturing practices. The reports are circulated to hospitals and pharmacies alerting them to refrain from prescribing and stocking drugs found to be of substandard quality.

Currently, the department is manned by 33 inspectors out of 61 sanctioned strength and it requires totally about 210 Inspectors. 24 newly recruited Drug Inspectors are undergoing training, informed Dr Jagashetty.

No Comments »

Avatar of admin

by admin

DIPSAR finds 5 Ayurveda products sold in India mixed with sildenafil or tadalafil

September 21, 2010 in pharma industry

Officials in the Delhi Institute of Pharmaceutical Sciences & Research (DIPSAR) have confirmed that five ayurvedic formulations currently marketed in the country by various manufacturing companies are adulterated and mixed with sildenafil or tadalafil (phosphodiesterase) including Musli Power Xtra of Kerala. These five formulations, now available in the market, are combinations of allopathic and ayurvedic contents.

This was disclosed to Pharmabiz by the officials of DIPSAR in an email interview. According to sources, the institute has conducted investigations on 15 marketed preparations and of these, five were found to contain either sildenafil or tadalafil.

The products are ‘Supersonic’, manufactured by Renovison Exports Pvt. Ltd Federal, A&K Road, Patna , ‘Titanic K2’, manufactured by Sun Laboratories (P) Ltd. ORAI, UP, ‘Sikander e Azam’ , a product of Hashmi Unani Pharmacy, Amroha, UP, ‘2 Much Gold’ , manufactured by Prince Pharma, Village David, Ludhiana, and ‘Musli Power Extra’, of Kunnath Pharmaceuticals, Moovattupuzha, Kerala.

Sources from the government institute said they have collected the samples of the drugs from the local chemists in Delhi and they have the bills for the same for records. Their tests lasted for six months to find out the real contents.

“Earlier we wrote an official letter to the DCGI regarding the adulteration and in response to that, DCGI gave order to state drug controllers to take action on the same. We officially received letters from state drug testing laboratories where they have demanded the standards for testing of these products and in fact asked for the method of analysis employed in our laboratory. We received such letter from Rajasthan state drug testing laboratory”, an official in the institute said.

When asked what kinds of ingredients their tests targeted and how many of them proved positive, the official replied that they had targeted sildenafil and tadalafil.” We investigated 15 marketed preparations and of these, five were found to contain one of the mentioned drugs”.

They said the method used for conducting the analysis test of the formulations are various types including the latest one by using HPTLC, HPLC and LC-MS instruments.

In the quantitative test using the above instruments it was found that all the five products were contained the ingredients of phosphodiesterase (sildenafil or tadlafil) with different quantities in mg per tablet or capsule.

In the drug ‘Supersonic’ (batch NO- 14) the sildenafil presence per tablet/capsule was ‘119.00 mg. In ‘Titanic K2’, (Batch No—27), it was 71.00 mg per tablet/capsule. Where as, in ‘Sikander e Azam’, (Batch No—2), the presence of sildenafil per tablet/capsule was 76.00 mg.

The same content was also found in the drug, ‘2 Much Gold’,( Batch No—152), and the quantity was 2.01 mg per tablet/capsule. In ‘Musli Power Extra’, (Batch No–MP/058/09 ) the ingredient found was tadalfil and the amount present per capsule was 32.00 mg.

The officials said herbal medicines rarely have a quick onset of action and it is often seen that they produce mild to moderate action. Furthermore they elicit their response on prolonged dosing. The manufacturers of these companies were claiming to cure the problem of erectile dysfunction with single dose. This was contrary to the popular belief about the herbal drugs and that is what prompted them to carry out research to find out the truth behind their claims.

DIPSAR has sent the reports to the DCGI and copies were sent to the CDSCO offices and also to the health ministries of central government and Delhi government. It has advised the concerned authorities to conduct strict pharmacovigilance of these herbal products and they should be prohibited from marketing openly to public.

As per the Drugs & Magic Remedies Act “any such product used for the cure of sexual dysfunction cannot be advertised”. But manufacturers of these products are advertising on a large scale.

7 Comments »