drug import licence india
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Drug Import Licence

Drug Import Licence | drug import licence india | Scoop.it

In India import, manufacturing, distribution and sale of drug is synchronized under Drugs and Cosmetic Rules 1945 (hereinafter refer as Act) and Drugs and Cosmetics Act 1940 and made there under. In the current scenario, finished formulations and mass drug (Active Pharmaceutical Ingredients) are synchronized under the said Act. Any material falling within the description of drug (Section 3b of the Act) compulsory to be registered previous to making an import into the state. Not just drug but the industrialized site ought to be indexed for import. If the medicine, is counted within the description of latest Drug (Rule 122 E of the Act), the novel drug endorsement is the condition for compliance of appliance for Registration or trade in of drug.

 

The appliance for Registration and import can be completed to the certifying Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, New Delhi by the limited Authorized Agent of the overseas manufacturer having whichever sale or manufacturing License or by the overseas manufacturers‘ possessing a comprehensive License in the country. The Drugs & Cosmetics Act, 1940 regulates the drug import license in India along with manufacture, sale and distribution of drugs in India.

 

The worth of export of pharmaceuticals and drugs has greater than before to Rs. 24,942 crores in 2006- 07 from approximately Rs. 22,216 crores in 2005-06. Though, the imports of pharmaceutical and medicinal commodities have been approximately Rs. 5867.3 crores (conditional) in the year 2006-07. Furthermore, growing number of Indian pharmaceutical companies have been achieving international authoritarian approvals for their manufacturing plants from agencies like MHRA (UK), USFDA (USA), MCC (South Africa), TGA (Australia), Health Canada, and various others. India has the biggest quantity of USFDA approved manufacturing plants for general manufacture. Most important Indian companies are now on the lookout for more Abbreviated New Drug Approvals (ANDAs) in USA in dedicated segments like cardiovascular, anti infective and central nervous system groups.

 

The most important activities conducted in the Pharmaceutical division of the subdivision communicate to the expansion of the pharmaceutical industry, that is, its exports, production, imports, pricing, R&D, duty matters, etc. There is an 'Export Promotion Cell' in the department that acts as a nodal organization in the subjects associated to export of pharmaceuticals. The unit brings together statistical data on import or export of pharmaceuticals in the nation as well as embark on promotional actions for the speeding up of selling it to other countries.

There is an involved administrative centre of the Division, recognized as 'National Pharmaceutical Pricing Authority (NPPA)’, which keeps a look after price revision/ fixation of pharmaceutical and erstwhile associated subjects.  Generally, the role of NPPA is to:-

 

Enforce and implement the requirements of the Drugs (Prices Control) Order in agreement with the authority entrusted to itTransact with all officially permitted subjects arising out of the judgments of the AuthorityKeep an eye on the accessibility of drugs, recognize scarcities, if any, and to obtain corrective stepsMaintain or collect data on exports and imports, production, market share of companies, productivity of companies, etc. for formulations and bulk drugsRecruit the staff members of the Authority, in accordance with the rules and measures as formulated by the Government
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Clinical Research In India: Can It Survive?

Clinical Research In India: Can It Survive? | drug import licence india | Scoop.it

The clinical research industry or the CDSCO India is in a desperate need of a booster. The clinical research industry of India is quite a traditional player which is purely driven by bioequivalence studies for the generic drugs which are off patent and are tested on human volunteers who are healthy and right for the testing. The bioequivalence studies and its business is termed to be a business which is least associated with risk. It is one trade which has got returns that are guaranteed which was so from the year 2005 to 2009.

 

The pharmaceutical business was quite smooth till the year 2007 and has been a growth source in the market for the CRO’s who are known to be associated with the studies of bioequivalence for the Pharmaceutical firms of India. The firms outside India are the drivers of growth especially of the CRO market of India. A very similar story is true for the clinical studies which are patient based and are done at recognized, registered and specified hospital sites.

 

However, the Indian government with the effort and aim of streamlining the laws in country for the clinical researches is now making it hard for the routine submissions at CDSCO India. It is because of these conditions, that the existing units of clinical research with its proven records are now facing some serious setbacks. Some of the industry leaders have now in Unison raised their concerns with the authorities.

The authorities at their end have assured that the process will be sped up but the question remains the same as of the time that will be required in the entire process. Also the government has told that it has found certain flaws in the pattern and the process of the conduction of the clinical trials in pattern of the research companies.

 

The authorities has sent the circulars to the foremost CRO’s in India and the pharmaceutical firm to furnish the requisite data on the events and the deaths caused due to the clinical research and studies. It is normally declared at a continuous basis and is forwarded to the specified committees of CDSCO for the action plans that needs to be executed further. The committee after the analyzing of details has recommendations for the entire process. Certain recommendations are mentioned as follows:

 

The registration is mandatory for the ethics committee

The registration should be made mandatory and for filing the events in the clinical trials for accidents

Registrations should be made compulsory for the facilities where trials are to be conducted

Norms need to be made stringent especially when considered with the investigators and the training of the relevant individuals and workforce is made essential for the activities that come under the emergency category and in occurrence of some adverse events

Ascertaining compliance to the Schedule Y and also the ICH-GCP guidelines in order to conduct clinical trials

 

During the last couple of years, the above mentioned norms are outlined, majority of the clearances and certifications that are necessary have been a bit slow or are at hold for considerably longer span of time than the period which is stipulated normally for the process of approval.

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CDSCO India

CDSCO India | drug import licence india | Scoop.it

CDSCO in India as the Central Drugs Standard Control Organisation has set up an Expert Committee in consultation with the clinical experts along with formulating their GCP guidelines to generate clinical data on drugs. There has been an endorsement by the Drug Technical Advisory Board including the adoption of this GCP guideline to streamline the clinical studies in India. The Drug Technical Advisory Board is the highest technical body under D&C.

 

The clinical research industry of India desperately needs a growth booster. Since the year 2005, the Indian clinical research industry has been a very conventional player driven by purely bioequivalence studies for off patent generic drugs on the volunteers of human health. It is recognized a least risk associated business involving bioequivalence studies. The business also guaranteed sure returns in the prime growth period of this industry post 2005 till 2009. Till 2007, the business in this field was smooth and it has also been the source of the growth of the markets for CRO’s who have been doing bioequivalence studies for pharmaceutical companies. Bioequivalence studies of the US based Pharmaceutical firms outside India have been driving growth of the Indian CRO market.

 

This story is as similar as for the patient based clinical trial studies at registered, specified and recognized hospital sites.

However, Indian government has brought about the efforts of streamlining laws in the country for clinical research that has started applying brakes even on the routine submissions at the CDSCO. Resulting to it, many existing units of clinical research that have proven their track records facing severe setbacks. Due to it, many industrial leaders and researchers have united together to voice for their concerns to the government bodies. The government has reassured from its side that it will speed up the process but requires to be seen as to how long the waiting time will be. In reply, the government has stated that these laws and regulations are for detecting possible flaws in the pattern and process of conducting clinical trials by the clinical research companies.

 

All the major Indian CRO’s and Pharmaceutical companies of India have received circulars by the government to furnish data on the adverse events as well as deaths in the clinical research and studies. Generally, the same is declared on a routine basis by all and has been further forwarded to the concerned CDSCO’s committees for further plans of action. After analyzing the details, these committees have suggested certain recommendations for the process. According to them, the ethics committee should be registered mandatorily. All the adverse events in all the clinical trials should also be mandatorily registered and filled along with registering the facility where the trials are conducted.

 

These rules also cover the stringent norms related to training and investigators of all the relevant people for emergency activities during the occurrence of the adverse events. In compliance with the Schedule Y and ICH-GCP guidelines the clinical trials are required to be conducted. The above norms have been outlined during the time, the NOC certification and regulatory clearances should also be kept for longer time than the stipulated period of approval. Seeing the results, many of the western clients have withdrawn their outsourcing business along with deciding that the clinical trials will be conducted in other emerging nations.

 

 

 

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A Guide to the International Drugs

A Guide to the International Drugs | drug import licence india | Scoop.it

Individuals from all the age groups may at some time or the other require certain kind of medication. The drug prices in developed countries are quite high in nature and expensive for the common people. Also there happens to be the International Drug concept that is receiving or importing the drugs out of the international markets and not via the home market. It is a very common scenario in the North American parts where drugs are imported through Canada and Mexico. Accessibility to internet makes it quite simple for the individuals to receive the drugs at some considerably lower prices from the countries nearby them.

 

It is very crucial and has turned out to be a matter to be studied as hazards related to drug imports are quite high and there are chances that individuals may receive drugs that are not tested are of sub standard qualities. No regulations are in process in order to confirm authenticity of international drugs. It turns out to be quite an easy bait as the lower prices are always welcome by the customers. The drug import license is highly acknowledged by the customers as it provides them with the necessary drugs at a cheaper price. By the start of 21st century an approx of 30% of the patients in America were known to import the drugs online and the cheap prices being the most influencing factor.

 

Drugs are scrutinized properly prior of providing or granting the production licenses by FDA but with the scenarios of the imported medicines the quality of drugs can be a real question. The customers need to understand the risks and the potential harm that is associated with these types of drugs. Not just the standard of the drugs are in question here but also the potency and the ingredients of drugs might vary from one country to another. The U.S. market size is quite larger than the bordering countries of Canada and Mexico. Therefore, to cater increasing needs of the American customers and the Mexican and the Canadian pharmacies are vigorously trying to enhance the sales via the net.

 

The practices of importing the drugs and also its sale devoid of the approval of the Drug and the food authorities are illicit in most of the countries and also with the States. In spite that, several institutions and also some towns are known of saving huge chunks of money by making imports of drugs from other countries. The drug import license is a certificate which is essential and can be used to save life of millions. Hence, it is necessary to investigate the drug norms of Mexico and Canada and if they happen to be in coherence with the standards and laws of America.

 

The authorities have identified certain drugs, which has been recommended to not to be imported outside the country which is because the drugs are of substandard and also because some of them are controlled drugs and can be harmful for the consumers. However, accessing the same kind of drugs from the country can turn out to be an issue as they are very costly in nature and cannot be afforded by the common people.

 

 

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