CDSCO: the import registration and licence route

Three separate rulebooks sit behind the letters CDSCO, and which one applies decides the forms, the authority and the wait. Drugs go through the Drugs Rules, 1945 made under the Drugs and Cosmetics Act, 1940. Cosmetics go through the Cosmetics Rules, 2020, made under sections 12 and 33 of the same Act. Medical devices and in vitro diagnostics go through the Medical Devices Rules, 2017, notified by G.S.R. 78(E) dated 31-01-2017. The first question on any purchase order is therefore which of the three the goods fall into.

Why is the registration a separate step from the licence?

Because the rules make one a condition of the other. Rule 24(1) of the Drugs Rules, 1945 provides that an application for an import licence shall be made in Form 8 for drugs other than those in Schedule X, and in Form 8A for Schedule X drugs. Rule 24(2) then provides that any such application shall be accompanied by a copy of the Registration Certificate issued in Form 41 under rule 27A. The licence permits the import. The registration certificate is what the licence is built on, and it registers the overseas premises as much as the product.

There is one relief and one carve out. A proviso to rule 24(2) allows the licensing authority, with the approval of the Central Government and for reasons recorded in writing, to issue an import licence in Form 10 or 10A without a registration certificate in cases of emergency. A further proviso provides that a registration certificate is not required with an application for an import licence for in vitro diagnostic kits and reagents, except for diagnostic kits notified under sub-clause (iv) of clause (b) of section 3.

Who can actually be the applicant?

Not the Indian buyer as such. Rule 24A(1) of the Drugs Rules, 1945 provides that an application for a registration certificate shall be made in Form 40 either by the manufacturer himself, having a valid wholesale licence for sale or distribution of drugs under the rules, or by his authorised agent in India, either holding a licence to manufacture for sale of a drug or a valid wholesale licence for sale or distribution. Rule 24A(2) provides that the authorisation shall be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate or in the country of origin before an equivalent authority whose certificate is attested by the Indian Embassy, with the original furnished along with the application.

That single sub-rule is where most timelines slip. A power of attorney that has to be executed abroad, authenticated locally and attested by a mission is a document with its own lead time, and it sits in front of an application that has not yet started its own statutory clock.

How long does the registration take, and what does it cost?

Nine months, with a defined extension. The proviso to rule 27A(1) of the Drugs Rules, 1945 provides that if the application is complete in all respects and the information specified in Schedules D-I and D-II is in order, the licensing authority shall issue the registration certificate within nine months from the date of receipt of the application, and that in exceptional circumstances and for reasons recorded in writing it may be issued within such extended period, not exceeding three months, as the authority deems fit. Rule 27A(2) gives the applicant an appeal to the Central Government where the certificate does not arrive within that period.

The fees sit in rule 24A(3) and are stated in dollars. A fee of US$ 10,000 or its equivalent in Indian rupees is payable with Form 40 as registration fee for the premises meant for manufacturing drugs for import into India, and US$ 5,000 or its equivalent for the registration of a single drug, with an additional US$ 5,000 for each additional drug. Rule 24A(5) makes the applicant liable for US$ 25,000 or its equivalent for the expenditure of an inspection or visit of the manufacturing premises. On the licence side, rule 24(1) sets a fee of Rs 10,000 for a single drug and Rs 1,000 for each additional drug.

How long do the artefacts last?

Three years each, with different renewal windows. Rule 28A of the Drugs Rules, 1945 provides that a registration certificate, unless sooner suspended or cancelled, shall be valid for three years from the date of issue, with a proviso that if the application for a fresh certificate is made nine months before expiry, the current certificate is deemed to continue in force until orders are passed. Rule 28 provides the same three year validity for the import licence, with the equivalent proviso set at three months before expiry.

Those two windows, nine months and three months, are the diary entries that matter. They are set where they are because they mirror the processing time, and an application made later than the window is an application whose gap is not covered by the deeming provision. Certification artefacts belong on a validity register rather than in a folder, which is the same argument the EXIM compliance calendar makes about every obligation that carries a validity rather than a date.

What changes if the goods are a medical device?

The rulebook and the forms both change. Under the Medical Devices Rules, 2017, CDSCO's own regulatory pathway document records that an import licence is applied for in Form MD-14 and granted in Form MD-15 by the Central Licensing Authority, for Class A, B, C and D devices alike, with fees as per the Second Schedule to those rules, and that applications are submitted through the medical devices online portal. A test licence for import, for product development, is applied for in Form MD-16 and granted in Form MD-17.

The classification is therefore not a filing detail. It decides which authority grants what, and for devices the Central Licensing Authority holds the import licence across all four risk classes even though manufacturing licences for Class A and B sit with the State Licensing Authority. We could not confirm the validity period of an MD-15 licence from an official document we were able to read, so check the Medical Devices Rules, 2017 as in force on your own dates before assuming one.

What changes if the goods are cosmetics?

The registration becomes the whole of the gate, and it does not expire. Rule 12(1) of the Cosmetics Rules, 2020 provides that no cosmetic shall be imported into India unless the product has been registered by the Central Licensing Authority. Rule 12(2) provides that the application shall be made through the online portal in Form COS-1 either by the manufacturer himself or by his authorised agent or the importer in India or by the subsidiary in India authorised by the manufacturer. Rule 13(1) provides that the Central Licensing Authority may grant the import registration certificate in Form COS-2, or reject the application with reasons recorded in writing, within six months from the date of application.

Rule 14(1) then provides that a registration certificate granted under rule 13 remains valid in perpetuity, subject to payment of a retention fee before completion of the period of five years from the date of issue, unless suspended or cancelled. Rule 14(2) provides that a holder who misses that due date pays a late fee at two percent of the retention fee for every month or part of a month within one hundred and eighty days, and that on non-payment during that period the registration certificate shall be deemed to have been cancelled. A cosmetics registration therefore fails silently rather than expiring visibly.

What does this mean for a purchase order?

That the CDSCO question is answered before the supplier is confirmed, not before the vessel sails. A drug registration with a nine month statutory clock in front of an import licence that cannot normally be applied for without it is not a clearance task. It is a sourcing decision with a lead time attached, and it is measured against the same asymmetry every eligibility gate has: acting early costs a form and a fee, acting late costs demurrage on goods that cannot lawfully land.

Purser holds these artefacts against the specific product and manufacturing site on a purchase order, with their expiry and their renewal window, so a certificate that lapses in ninety days raises the question before an order is placed against it. Purser never submits to a government portal, and it never sends an outbound message without a recorded human approval event. It does not obtain a registration or a licence, and it does not replace the customs broker or the regulatory consultant.

Where to go from here

CDSCO is one gate among several, and the ones that share a purchase order are worth reading together.

• The survey of what blocks a consignment. What stops a container at the port puts certification, trade remedy and origin in a single view.
• The mechanics of a quality control order. Quality control orders, the transition route and its dates reads one gazette order clause by clause.
• The registration scheme next door. BIS compulsory registration for electronics covers the parallel route for electronics and IT goods.
• Where validity sits on the calendar. The EXIM compliance calendar lists the obligations that carry a validity rather than a fixed date.
• The document set at the port. Documents required to import into India shows where a licence copy is expected in the clearance file.

Frequently asked questions

Do you need a registration certificate before an import licence for drugs?

Normally yes. Rule 24(2) of the Drugs Rules, 1945 provides that any application for an import licence in Form 8 or Form 8A shall be accompanied by a copy of the Registration Certificate issued in Form 41 under rule 27A. A proviso allows the licensing authority, with the approval of the Central Government and for reasons recorded in writing, to issue an import licence in Form 10 or 10A without a registration certificate in cases of emergency, and a further proviso exempts in vitro diagnostic kits and reagents other than notified diagnostic kits.

How long does CDSCO take to issue a Form 41 registration certificate?

Nine months, with a defined extension. The proviso to rule 27A(1) of the Drugs Rules, 1945 provides that where the application is complete in all respects and the information specified in Schedules D-I and D-II is in order, the licensing authority shall issue the registration certificate within nine months from the date of receipt of the application, extendable in exceptional circumstances and for reasons recorded in writing by a further period not exceeding three months. Rule 27A(2) gives the applicant an appeal to the Central Government if it does not arrive in that period.

Who can apply for a CDSCO import registration certificate?

The overseas manufacturer or an authorised agent in India. Rule 24A(1) of the Drugs Rules, 1945 provides that the application in Form 40 is made either by the manufacturer himself holding a valid wholesale licence for sale or distribution of drugs, or by his authorised agent in India holding either a licence to manufacture for sale of a drug or a valid wholesale licence. Rule 24A(2) requires the authorisation to be a power of attorney authenticated in India before a First Class Magistrate or abroad before an equivalent authority with the certificate attested by the Indian Embassy.

How long is a CDSCO drug import registration certificate valid?

Three years. Rule 28A of the Drugs Rules, 1945 provides that a registration certificate, unless sooner suspended or cancelled, is valid for three years from the date of issue, with a proviso that where an application for a fresh certificate is made nine months before expiry the current certificate is deemed to continue in force until orders are passed. Rule 28 gives the import licence the same three year validity, with the equivalent proviso set at three months before expiry.

Does a cosmetics import registration in India expire?

Not by date, but it can be deemed cancelled. Rule 14(1) of the Cosmetics Rules, 2020 provides that a registration certificate granted in Form COS-2 remains valid in perpetuity, subject to payment of a retention fee before completion of five years from the date of issue, unless suspended or cancelled. Rule 14(2) provides that a late payment attracts a late fee of two percent of the retention fee for every month or part of a month within one hundred and eighty days, and that non-payment during that period means the registration certificate is deemed to have been cancelled.