Cialis from India – types, quality of products and legality in the USA.

India is the state, which supplies about 40% generics and over-the-counter (OTC) products consumed in the US. It is the second largest exporter of pharmaceutical products after Canada.

Generic Cialis India

There are several Indian producers of a generic version of Cialis anti-ED remedy. They are listed below:

cialis-from-india1) Aurochem Laboratories is a company having 30 years of experience in the drug market. It produces generics in the form of pills and jelly;
2) Cipla is one of the oldest Indian drug producers. It manufactures tadalafil generics in the form of pills (10 and 20 mg);
3) German Remedies Pvt. is a firm which produces a number of medicaments including tadalafil “copies” in compliance with ISO 9002 standards;
4) Ranbaxy Laboratories Ltd is a manufacturer having more than 50 years of experience. It produces medicament Vidalista containing 20 mg of tadalafil.

Legal issues

Eli Lilly (the manufacturer of branded Cialis) possesses a US patent for the medicament valid until 2017. So, Cialis from India is illegal in the US until the expiry of the patent on the US territory. In 2014, Eli Lilly announced a licensing contract with a French company called Sanofi S.A. According to the contract, Sanofi S.A. will have a right to sell a generic OTC version of the medicament in US and other countries. Sanofi will need to receive the permission from state regulators before releasing the generic on the market.

Quality of Indian generics

Since the Indian generics of Cialis are illegal in the United States, their quality is questionable. But even legal generic versions of other drugs that are imported to the US from India, do not always have good quality. For instance, in 2014, FDA, due to the discrepancies between the product quality and the established norms, including manipulation of the control results and poor sanitary condition of production facilities, has banned the export of products of some Indian pharmaceutical firms. In addition, a number of Indian companies announced a voluntary withdrawal of certain batches of its products from the market. So, Ranbaxy has withdrawn from sale in the United States more than 64 thousand vials of generic of hypocholesterolemic Lipitor medicament. This was caused by the fact that the amount of active agent of the medicament was increased by 2 times (20 mg instead of required 10 mg). Sun company has withdrawn from sale approximately 2.5 thousand vials of antidiabetic generics, when in one of them antiepileptic substance was found. Dr. Reddy’s took the same decision in respect of more than 58 thousand vials with lansoprazole generic used for treating heartburn, because microorganisms were detected in some vials.

Is it legal to import unapproved medicaments?

According to US FDA, in most cases, the import of generic medicaments that are not approved in the United States is illegal even for personal use. Such policy is carried out because the state regulator cannot ensure the safety of medical remedies, which are not subject to state control. However, in some cases, people can import medicaments for personal use. For example, the import is permitted if:
(1) a medicament is aimed at the treatment of serious ailments for which effective remedies are not available in the US;
(2) a person does not carry a drug for the purpose of advertising and promotion;
(3) a person confirms in written form, that he/she will use the medicament personally, and gives FDA contact of a foreign doctor who has prescribed the medical remedy.